CLINICAL EVALUATION REPORT

Silistab® Malleo, MalleoPro Activ and Ligastrap Malleo®

version 1.0

THUASNE
120 rue Marius Aufan
CS10032
92309 Levallois-Perret Cedex
FRANCE
 Clinical Evaluation Report

TABLE OF CONTENTS
Table of Contents ........................................................................................................................................ 2
1 Scope of the clinical evaluation ........................................................................................................... 4

1.1 Introduction .................................................................................................................................................................................. 4

1.2 Description of the device .............................................................................................................................................................. 4
General description .................................................................................................................................................................. 4
1.2.1.1 Name ............................................................................................................................................................................................................... 4
1.2.1.2 Main components / models / sizes ........................................................................................................................................................... 5
1.2.1.3 Identification of the manufacturer ............................................................................................................................................................ 6
Device group ............................................................................................................................................................................. 6
Intended purpose of the device ............................................................................................................................................... 6
1.2.3.1 Ligastrap® Malleo ....................................................................................................................................................................................... 6
1.2.3.2 Silistab® Malleo ............................................................................................................................................................................................ 7
1.2.3.3 MalleoPro activ ............................................................................................................................................................................................. 7
Intended performance and claims............................................................................................................................................ 7
1.2.4.1 Technical performances intended by the manufacturer ...................................................................................................................... 7
1.2.4.2 Intended clinical benefits and Claims regarding clinical performances .......................................................................................... 7
1.2.4.3 Claims regarding clinical safety ............................................................................................................................................................... 7

2 Literature Search ................................................................................................................................. 7

2.1 Medical fields concerned and relevant medical conditions. ......................................................................................................... 7

2.2 Documents search Methodology .................................................................................................................................................. 8
Databases ................................................................................................................................................................................. 8
Methodology ............................................................................................................................................................................ 8
Main Keywords and combinations ........................................................................................................................................... 8
Period ....................................................................................................................................................................................... 9
Results ...................................................................................................................................................................................... 9
2.3 State of the art ............................................................................................................................................................................ 10
Ankle anatomy ........................................................................................................................................................................ 10
Pathologies ............................................................................................................................................................................. 11
2.3.2.1 Traumatic conditions ................................................................................................................................................................................... 11
2.3.2.2 Other conditions .......................................................................................................................................................................................... 11
Treatments ............................................................................................................................................................................. 11
2.3.3.1 Conservative treatments............................................................................................................................................................................ 11
2.3.3.2 Surgical treatments ..................................................................................................................................................................................... 13
2.4 Risk analysis ................................................................................................................................................................................. 13
2.5 Summary of clinical evidence ...................................................................................................................................................... 13

3 Device under Evaluation .................................................................................................................... 16

3.1 Type of evaluation ....................................................................................................................................................................... 16

3.2 Demonstration of equivalence .................................................................................................................................................... 16

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Strategy of equivalence .......................................................................................................................................................... 16

Comparison with potential equivalent device ........................................................................................................................ 16
Discussion about similarities and differences ......................................................................................................................... 18
3.2.3.1 Clinical conditions – indications S(1) ...................................................................................................................................................... 18
3.2.3.2 Contraindications D .................................................................................................................................................................................... 18
3.2.3.3 Product characteristics S(2) ...................................................................................................................................................................... 18
3.2.3.4 Range of products S(3) ............................................................................................................................................................................. 18
3.2.3.5 Composition S(4) ......................................................................................................................................................................................... 18
3.3 Clinical data generated and held by the manufacturer ............................................................................................................... 18
Clinical study ........................................................................................................................................................................... 18
3.3.1.1 Scope ............................................................................................................................................................................................................. 18
3.3.1.2 Method .......................................................................................................................................................................................................... 19
3.3.1.3 Results and discussion ................................................................................................................................................................................. 19
3.3.1.4 Conclusion ..................................................................................................................................................................................................... 20
Vigilance ................................................................................................................................................................................. 20
Complaints .............................................................................................................................................................................. 20
3.4 Literature review on equivalent device ....................................................................................................................................... 21

4 Conclusions ........................................................................................................................................ 22
5 Date of next clinical data ................................................................................................................... 22
6 Dates and signatures ......................................................................................................................... 23
List of Appendices ..................................................................................................................................... 24

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 Clinical Evaluation Report

1 SCOPE OF THE CLINICAL EVALUATION

1.1 INTRODUCTION
This clinical evaluation is submitted to the MDD as amended by directive 2007/47/EC.

This Clinical Evaluation Report (CER) is a dynamic document based on available clinical data.
This document is revised and updated:
- if the manufacturer receives new information from PMS that has the potential to change the current evaluation,
- in case of a significant modification of the product,
- in case of a significant modification in the user’s or patient information,
- at least every 5 years
When updating the clinical evaluation, the evaluators verify
- if the benefit/risk profile, undesirable side-effects and risk mitigation measures are still
o compatible with a high level of protection of health and safety and acceptable according to current knowledge/ the
state of the art;
o correctly addressed in the information materials supplied by the manufacturer of the device;
o correctly addressed by the manufacturer's current PMS plan;
- if existing claims are still justified;
- if new claims the manufacturer intends to use are justified.

1.2 DESCRIPTION OF THE DEVICE

General description

1.2.1.1 Name
The following products are covered by this CER:

- LIGASTRAP® MALLEO;
- SILISTAB® MALLEO;
- MALLEOPRO ACTIV.

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1.2.1.2 Main components / models / sizes

The devices covered by this CER are available in multiple sizes:
Table 1: Characteristics of LIGASTRAP® MALLEO, SILISTAB® MALLEO and MALLEOPRO ACTIV devices.

Reference Name Size Picture

2180 03 201 001 99 1

2180 03 202 001 99 2

2180 03 203 001 99 3

LIGASTRAP® MALLEO - Grey
2180 03 204 001 99 4

2180 03 205 001 99 5

2365 01 201 000 99 1

2365 01 202 000 99
2
2365 01 203 000 99
3
2365 01 204 000 99 SILISTAB® MALLEO - White
4
2365 01 205 000 99
5
2365 01 206 000 99
6
2365 01 201 003 99 1
2365 01 202 003 99 2
2365 01 203 003 99 3
2365 01 204 003 99 SILISTAB® MALLEO - Black 4
2365 01 205 003 99 5
2365 01 206 003 99 6
2365 01 201 002 99 1
2365 01 202 002 99 2
2365 01 203 002 99 3
2365 01 204 002 99 SILISTAB® MALLEO - Beige 4
2365 01 205 002 99 5
2365 01 206 002 99 6
2368 02 201 001 01 1
2368 02 202 001 01 2
2368 02 203 001 01 MALLEOPRO ACTIV – RIGHT 3
2368 02 204 001 01 - Grey 4
2368 02 205 001 01 5
2368 02 201 001 02 1
2368 02 202 001 02 2
2368 02 203 001 02 MALLEOPRO ACTIV – LEFT - 3
2368 02 204 001 02 Grey 4
2368 02 205 001 02 5
2368 02 201 003 01 1
2368 02 202 003 01 2
2368 02 203 003 01 MALLEOPRO ACTIV – RIGHT 3
2368 02 204 003 01 - Black 4
2368 02 205 003 01 5

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 Clinical Evaluation Report

2368 02 201 003 02 1

2368 02 202 003 02 2
2368 02 203 003 02 3
2368 02 204 003 02 4

MALLEOPRO ACTIV – LEFT -

Black
2368 02 205 003 02 5

Their composition is as follow:

- LIGASTRAP® MALLEO: polyamide, polyester, elastane, elastodiene and neoprene;

- SILISTAB® MALLEO: polyester, covered elastan, covered elastodiene and viscose;
- MALLEOPRO ACTIV: polyamide, polyester, elastane and elastodiene.

The device does not use/incorporate any software.

1.2.1.3 Identification of the manufacturer

THUASNE
120 rue Marius Aufan
CS10032
92309 Levallois-Perret Cedex
FRANCE

Device group
According to the Annex IX, rule 1 of the medical device directive 2007/47/CE, the MALLEO range from Thuasne is in class I: ‘All non-invasive
devices are in Class I, unless one of the rules set out hereinafter applies’.

Furthermore, the MALLEO range from Thuasne is defined by the following GMDN code: 36206 orthosis, leg, ankle/foot, unit.

Intended purpose of the device

1.2.3.1 Ligastrap® Malleo

Ligastrap® Malleo is indicated for the functional treatment of moderate sprains of the outer lateral ligament, resumption of occupational
activities and sport after moderate to serious sprains and chronic hyperlaxity. The product contraindications are the application in direct
contact with broken skin and allergies to thiurams.

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1.2.3.2 Silistab® Malleo

Silistab® Malleo is indicated for the malleolar protection of injured or vulnerable joints, compression of the ankle during treatment enabling
early resumption of physical activities and the prevention of oedema. The product contraindication is the application in direct contact with
broken skin.

1.2.3.3 MalleoPro activ

MalleoPro activ is indicated for post-traumatic, post-operative and chronic inflammation, sprains, joint effusions and oedema due to
arthritis and joint disease, and moderate joint instability. The product contraindication is the application in direct contact with broken skin.

Intended performance and claims

1.2.4.1 Technical performances intended by the manufacturer

Ligastrap® Malleo properties are:
- Elastic knit;
- Double lateral support strapping to maintain flexion/extension;
- Removable lateral support strap;
- Anti-slip system on the calf.

Silistab® Malleo properties are:

- Elastic ankle brace;
- Protective silicone padding;
- Protection of the malleolus and instep.

MalleoPro activ properties:

- Ankle brace in a two-way elastic flat knit;
- 3D knit at the malleoli;
- Integrated supination brake;
- External padding.

1.2.4.2 Intended clinical benefits and Claims regarding clinical performances

The clinical benefits and claims regarding the clinical performance of the MALLEO range are the limitation of the range of motion (ROM) in
the short term which prevent any further pain, the reduction of the oedema and then the healing of the ankle pain in the mid-term.

1.2.4.3 Claims regarding clinical safety

In terms of safety, the manufacturer claims a low rate of adverse-event related to the use of Ligastrap® Malleo, Silistab® Malleo and
MalleoPro Activ. In case of cutaneous reaction (redness, erythema), it is recommended to readjust or remove the brace.

2 LITERATURE SEARCH
2.1 MEDICAL FIELDS CONCERNED AND RELEVANT MEDICAL CONDITIONS.
Ligastrap® Malleo, Silistab® Malleo and MalleoPro Activ devices are used to relieve or prevent patient’s ankle pain.

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2.2 DOCUMENTS SEARCH METHODOLOGY

Databases
The databases used for the literature search are PubMed and Science Direct.

Methodology
The methodology used for the literature search is the PICO method (Patients / Population, Intervention, Comparators, Outcomes):

Table 2: PICO methodology.

Patient / Population Intervention Comparison Outcomes

All types of intervention for the
Patient with sprains, arthritis,
treatment of sprains, arthritis,
hyperlaxity, joint instability,
hyperlaxity, joint instability,
oedema or inflammation.
oedema or inflammation.
Assessment of the results
obtained for the treatment of
sprains, arthritis, hyperlaxity,
joint instability, oedema or
inflammation.
Comparison of the results
obtained with other
treatments.
Results required to analyze the
performance of the treatment:
• Clinical outcomes (pain,
disability, range of motion,
sprain recurrence, athletic
performance, …)
• Complications.

Main Keywords and combinations

The keywords used for the literature search are:
- Ankle;
- Malleolus;
- Brace;
- Orthosis;
- Compression;
- Strapping;
- Sprain;
- Arthritis;
- Oedema;
- Joint instability;
- Inflammation
- Hyperlaxity.

The keywords were combined as follow:

Table 3: Queries, filters and results.

Query ID Date Source Query Filters Results

1 17/06/2019
2 17/06/2019
(ankle OR malleolus) AND (brace OR
strapping OR compression OR orthosis) Species: Humans
PubMed AND (sprain OR arthritis OR oedema OR Languages: English, French 78
(joint instability) OR inflammation OR Date: 2017 – 2019
hyperlaxity) AND treatment
(ankle OR malleolus) AND (brace OR Species: Humans
PubMed strapping OR compression OR orthosis) Languages: English, French 7
AND (sprain OR arthritis OR oedema OR Date: 2017 – 2019

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Query ID Date Source Query Filters Results

(joint instability) OR inflammation OR
hyperlaxity) AND ((adverse effect) OR
(adverse event) OR complication)
(ankle OR malleolus) AND (brace OR Article type: research
strapping OR compression OR orthosis) articles, review articles,
3 17/06/2019 ScienceDirect AND (sprain OR arthritis OR oedema OR book review, practice 22
(joint instability) OR inflammation OR guidelines
hyperlaxity) AND treatment Date: 2017 – 2019
(ankle OR malleolus) AND (brace OR
Article type: research
strapping OR compression OR orthosis)
articles, review articles,
AND (sprain OR arthritis OR oedema OR
4 17/06/2019 ScienceDirect book review, practice 22
(joint instability) OR inflammation OR
guidelines
hyperlaxity) AND ((adverse effect) OR
Date: 2017 – 2019
(adverse event) OR complication)

Period
The research has been carried out the 17th June 2019 and filters have been applied to select the most relevant articles. Filters have been
applied such as article type, species or languages, depending of the database used.

Results
129 articles have been found for the literature review. The results of literature review are available in Appendix B – Search Report and in
Appendix C – Publications.

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2.3 STATE OF THE ART

Ankle anatomy
The ankle is composed of two joints:
- The true ankle joint, also called the talocrural joint;
- The subtalar joint.
The true ankle joint gathers several bones: the shin bone also called tibia, the fibula, next to the shin bone, and the talus. It allows up and
down movement (plantarflexion and dorsiflexion). These bones are linked between them by many ligaments (Figure 1). The subtalar joint
is beneath the true ankle joint and is composed of the talus and the calcaneus. It allows side-to-side motion of the foot.

Figure 1: Ankle anatomy

The protrusions felt on ankle bones are called malleoli (Figure 2). They are 3 of them:
- The lateral malleolus on the outside of the ankle which is on the low-end of the fibula;
- The medial malleolus on the inside of the ankle which is part of the tibial base;
- The posterior malleolus on the back of the ankle and part of the shin bone.

Figure 2: Malleoli of the ankle

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Pathologies

2.3.2.1 Traumatic conditions

Sprain:
A joint sprain is an overstretching of ligaments mainly due to physical activities or accidents. It is not to be confused with a joint strain
which corresponds to an overstretching of tendons and ligaments.

Ankle instability:
Ankle instability may occur after repetitive sprains for example. It is due to decreased proprioceptive abilities because of a loss of
mechanoreceptors and decreased muscle strength of invertor and evertor muscles.

Fracture:
Fracture of the ankle may result from a high-energy trauma. It can range from a simple break in one bone to multiple fractures in several
bones.

Tendinitis and tendinosis:

There are many tendons (Achilles tendon, posterior tibial tendon, tibialis anterior tendon, …) in the ankle and tendinitis/tendinosis may
occur. A tendinitis is an inflammation or an irritation of a tendon which anchors a muscle to a bone. It is due to a sudden trauma of the
musculotendinous unit. A tendinosis is a degeneration of the tendon’s collagen in response to chronic overuse, the injured tendon does
not have the time to heal.

2.3.2.2 Other conditions

Arthritis:
Arthritis is a degenerative condition which involves joint inflammation and swelling of the surrounding tissue. In the case of osteoarthritis,
there is a degeneration and a breaking down of the cartilage tissues. In what concerns rheumatoid arthritis, it is the body immune system
which attacks joint tissues causing inflammation (Stolt 2017). When crystals of monosodium urate are formed due to excess of uric acid,
they can deposit in the joint causing intense inflammation: it is called gout.

Hyperlaxity:
Hyperlaxity or hypermobility is a condition in which the tissues holding a joint together, mainly ligaments and the joint capsule, are too
loose (Blokland 2017). People with hypermobile joints may develop stiffness or pain in their joints.

Treatments
Treatments are gathered in two categories (Doherty 2016):
- Non-surgical / conservative treatments;
- Surgical treatments.

2.3.3.1 Conservative treatments

Before to consider surgical therapy, conservative treatments may be used (Bitterman 2017).

RICE therapy:
RICE stands for Rest, Ice, Compression and Elevation. Rest will give time to heal and the use of ice, compression and elevation help reduce
swelling and inflammation. It is recommended not to put the ice in direct contact with the skin in order to avoid burning (Vuurberg 2018).

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Orthosis:
Orthosis such as braces, splints, walking boots, or casts, according to the condition, may be used to immobilize, limit the ROM or compress
the ankle which will help with healing (Vuurberg 2018, Fellas 2017, Newman 2017, Feger 2016, Hadadi 2015, Louwerens 2018). Thus, they
can be more or less flexible according to the condition (Chapman 2019). They can also be used to facilitate physical functioning by reducing
pain (Tenten-Diepenmaat 2018).

Taping:
Ankle taping also called strapping is used to support the ankle and to prevent and treat ankle injuries. Many types of taping exist, and a
non-exhaustive list is presented below (Yen 2018, Fazeli 2018, Jahjah 2018, Sato 2017, Alves 2017, Dingenen 2017, Alguacil-Diego 2017,
Halim-Kertanegara 2016).

Distal fibular taping is a technique that does not restrict movement as much as conventional taping. Some researchers consider that this
technique adds tense additively in posterior direction (Simsek 2018, Fazeli 2018, Jackson 2017).

Kinesiology taping is an adhesive taping with heat-sensitive acrylic adhesive which facilitates or inhibits muscle function via cutaneous
stimulation depending on the technique applied (Yen 2018, Kim 2017, Farquharson 2017). It is often combined with physical therapy to
enhance its efficiency, although its efficiency is contested among the literature.

Footwear:
Therapeutic shoes/footwear are prescribed in case of abnormal foot function, deformity or malalignment (Tenten-Diepenmaat 2018,
Frecklington 2017, Wagner 2016, Fellas 2017). There can be ready-made or custom-made.

Medication:
The intended goal of a pharmacology therapy using drugs is the pain management (Vuurberg 2018).

The WHO (World Health Organization) ladder is a stepwise approach to the use of analgesics depending on pain severity. It is stratified in
3 steps:
- Step 1: use of non-opioid analgesics (aspirin, paracetamol or non-steroidal anti-inflammatory drugs such as ibuprofen);
- Step 2: use of mild opioids (codeine, hydrocodone, tramadol, …);
- Step 3: use of strong opioids (morphine, hydromorphone, oxycodone, fentanyl, or methadone).
Some adverse effects may occur especially for opioids and anti-inflammatory drugs such as delirium, sedation, nausea, constipation,
dependency, risks of renal injury, gastrointestinal bleeding and cardiovascular risks.

Steroid injection:
In the case medication is not effective to relieve the pain, steroid such as cortisone may be injected in the injured area. The problem with
steroid injections is that the tendon is very fragile between 10 days to 6 weeks after the injection.

Physical therapy:
Manual mobilization, done by a physical therapist, uses passive movement to the injured joint in specific direction and muscle stretching
to improve tissue extensibility, increase the ROM and induce relaxation. It is often combined with exercise therapy which consists on
neuromuscular and proprioceptive exercises (Bleakley 2018). They are associated with a quick time to recovery and enhanced outcomes
(Vuurberg 2018). Moreover, the physical therapist may use light emitting diodes or acupressure therapy to reduce pain and oedema (de
Moraes Prianti 2018, Zhao 2017).

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2.3.3.2 Surgical treatments

In case of serious ankle condition, surgery may be required.

Syndesmotic screw:
A screw is inserted through at least 2 bones to give time to the ankle to heal. After healing, the screw is removed. Infection at the surgical
site, improper alignment of the bones, pain or irritation may occur after surgery.

Ankle arthroscopic surgery:

It is a surgical procedure that uses a small tolls and camera thanks to fiber optics to operate in and around the ankle joint through small
incisions. With this procedure, several adverse events can occur such as infection, bleeding and nerve damage risks (Teramoto 2018,
Pellegrini 2018).

Ankle fusion surgery:

Ankle fusion, also called ankle arthrodesis, is used to fuse two bones together in order to reduce pain and to make the ankle joint more
stable (Zwipp 2017, Kruidenier 2018). This procedure is quite safe but infection, bleeding, painful scar, loosening or even nerve damage
may occur (Emara 2018).

Ankle replacement surgery:

Ankle replacement surgery, also called ankle arthroplasty, uses a prosthesis to replace the ankle joint. The main complications associated
with this technique are infection, pain and aseptic loosening.

2.4 RISK ANALYSIS

The main complications related to the wearing of an ankle brace are cutaneous reaction due to an allergic reaction to the fabric or tingling
sensation in the foot because the brace is too tight.

2.5 SUMMARY OF CLINICAL EVIDENCE

A total number of 129 articles were found according to the queries cited in Table 3. To obtain clinical evidence of the performance of ankle
brace used in the case of ankle injury, rejection criteria were defined as follow:
- No direct reference to the pathology or to the treatments;
- Duplicate data (especially data already included in the recommendations);
- No relevant data.
After reading of the title, 81 articles were rejected. After reading of the abstract, 6 articles were rejected. After reading of the full article, 3
articles were rejected. Thus, 39 articles were identified for the state of the art and for clinical evidence of the performance of ankle braces.

1 article was manually added regarding to demonstrate the performance of ankle braces.

Among the 39 articles selected for the state of the art, 7 articles were identified for clinical evidence of the performance; the other articles
were rejected because they did not contain relevant data for the assessment of performance and safety of the device under evaluation.
Performances of ankle braces were compared through different studies.

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Table 4: Performances related to the use of ankle braces.
Reference Pathology Treatment
Proprioceptive and
neuromuscular training (PNT)
Ankle sprains
Burger 2017 (balance board) VS bracing
(recurrence)
(Aircast A60 semi-rigid ankle
brace, DonJoy)
Customized foot orthoses
(IG: intervention group) VS
simple insoles (CG: control
group)
Rheumatoid
Gijon-Nogueron 2018 Functional foot orthoses (IG)
arthritis
VS placebo orthoses (CG)
Functional foot
Orthoses (IG) VS unshaped
Material (CG)
Unbraced VS Soft-shell lace-
up brace (Swede-Ankle Lok
Brace) VS Semi-rigid brace
(Air-Cast Air-Stirrup Ankle
Brace) VS Ankle taping (heel
locks taping technique)
Unbraced VS Lace-up ankle
Newman 2018 No pathology brace (ASO; Medical
Specialties Inc.) VS Semi-rigid
ankle brace (T2 Active Ankle;
Active Ankle Systems)
Unbraced VS Seattle Ankle
Orthosis (SAO; R&D Medical)
VS Lace-up ankle brace (ASO;
Medical Specialties Inc.) VS
Semi-rigid ankle brace
(Aircast Airsport; DonJoy)
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Performances
Number of patients: 220 (107 PNT / 113 bracing)
(Janssen 2014).
Follow-up: 12 months
Scores: Recurrence of ankle sprains
Results and conclusion: Recurrence of ankle sprains
was significantly lower for the bracing group compared
to the PNT group. Thus, athletes in the PNT group were
1.8 times more likely to sustain a recurrent ankle injury
than athletes in the bracing group.
Number of patients: 41 (20 IG / 21 CG) (Rome 2016).
Follow-up: 4 months.
Scores: Pain, disability, activity limitation and cost-
effectiveness.
Results and conclusion: There is an improvement in foot
pain and disability outcomes in patients with foot
orthoses but no statistically significant differences
were found between IG and CG.
Number of patients: 102 (52 IG / 50 CG) (Conrad 1996).
Follow-up: 36 months
Scores: Pain and disability.
Results and conclusion: There are no statistically
significant differences between IG and CG regarding
pain and disability outcomes.
Number of patients: 40 (20 / 20) (Novak 2009).
Follow-up: 6 months.
Scores: Plantar pressure, pain and walking ability.
Results and conclusion: There is an improvement in foot
pain outcomes in patients with foot orthoses but no
statistically significant differences were found between
IG and CG.
Number of patients: 10.
Follow-up: No follow-up.
Scores: Vertical jump test, right-boomerang run test and
modified bass test of dynamic balance.
Results and conclusion: Rigid braces limit functional
performances for specific activities contrary to flexible
braces. Clinicians may utilize ankle braces as a device
that provides protection without affecting a patients’
functional performance.
Number of patients: 36.
Follow-up: No follow-up.
Scores: Star excursion balance test.
Results and conclusion: Ankle braces have no
consequences on dynamic balance during a reaching
task.
Number of patients: 24.
Follow-up: No follow-up.
Scores: Vertical jump, balance error scoring system and
agility run.
Results and conclusion: All 3 braces reduced maximum
vertical jump height and ROM compared to the control.
Ankle braces may have minimal negative effects on
 Clinical Evaluation Report
Reference Pathology Treatment
Unbraced VS Lace-up ankle
brace (McDavid 199
Lightweight Ankle Brace;
McDavid Inc.)
Active Ankle T2® (Active
Ankle System) (semi-rigid) VS
Ankle Stabilizing Orthosis®
Tamura 2017 No pathology
(Medical Specialties) (lace-
up) VS closed basket weave
(Gibney) ankle taping
No brace (NB) VS neoprene
ankle wrap (AW) brace
(Model #4547, Mueller
Webster 2017 Ankle instability Sports Medicine) VS semi-
rigid plastic brace (AC)
(Aircast Air Stirrup Model
#02XX, DonJoy)
Combined Mechanism Ankle
Chronic ankle
Hadadi 2015 Support (CMAS) (rigid and
instability (CAI)
soft parts)
Ankle support (Malleotrain,
Acute ankle
O’Hara 1992 Bauerfeind) VS rest +
injuries
bandage
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Performances
performance measures for those seeking added ankle
protection.
Number of patients: 20.
Follow-up: No follow-up.
Scores: Accuracy shooting at a target with a soccer ball,
40 yard dash, S180° run and T test.
Results and conclusion: Lace-up ankle braces do not
statistically reduce any performance measures specific
to soccer compared to an unbraced condition.
Number of patients: 13.
Follow-up: No follow-up.
Scores: Athletic performance and energy expenditure
(ankle inversion-eversion excursion, maximal eversion
velocity, plantarflexion at toe off, maximal
plantarflexion, and maximal plantarflexion velocity).
Results and conclusion: In all ankle support, ankle
inversion-eversion excursion and maximal eversion
velocity were significantly decreased, especially for the
semi-rigid hinged ankle braced. Plantarflexion at toe off,
maximal plantarflexion, and maximal plantarflexion
velocity were significantly decreased in the lace-up
ankle brace and tape, while maximal dorsiflexion
velocity was significantly decreased only in tape. Energy
expenditure was not significantly increased in lace-up
ankle brace condition compared to control.
Number of patients: 12.
Follow-up: No follow-up.
Scores: Ankle joint position sense and stiffness.
Results and conclusion: AC brace provides more
effective ankle support compared to NB or AW brace
conditions. AW brace may not compensate for losses in
physiological stiffness. AW has better scores for females
than males.
Number of patients: 40 (20 with CAI and 20 healthy
patients).
Follow-up: No follow-up.
Scores: Postural sway.
Results and conclusion: Sway parameters in CAI patients
with CMAS orthosis were lower than without. There
were no significant differences in the healthy group
between two orthotic conditions. The CMAS orthosis is
an effective device for improvement of static balance in
CAI patients.
Number of patients: 220 (118 Malleotrain / 102 control).
Follow-up: 2 weeks.
Scores: Pain (VAS), limitation of activity, ability to work,
comfort, ease to use and improvement.
Results and conclusion: Pain improvement was greater
in the group on Malleotrain. Malleotrain ankle support
results in more rapid alleviation of symptoms than does
Tubigrip and is acceptable to patients. Malleotrain
should therefore be considered in the management of
all patients with such injuries.
 Clinical Evaluation Report

It appears that ankle braces are efficient to reduce pain (VAS scores). They are far more efficient that simple bandages with rest. They help
reducing ankle sprain recurrence thanks to their support they provide during sport activities and are more efficient physical therapy in this
way. Sometimes, flexible or soft ankle braces are preferred because they do not limit the ROM as much as rigid orthosis do.

3 DEVICE UNDER EVALUATION

3.1 TYPE OF EVALUATION
The clinical evaluation is based on the available scientific literature and all available clinical / clinically pertinent data on the devices under
evaluation and on equivalent devices. This evaluation includes:
- The result of clinical investigations and other clinical studies (including PMCF studies) performed on the device / its equivalent;
- Clinical data from PMS and PMCF activities, including materiovigilance;
- Data on compliance with harmonized standards pertaining to the device, especially vertical standards specific to the device;
- All relevant data from a targeted document search, including incident and alerts databases and function of the state of the art
for the device and similar devices;
- Clinically relevant preclinical data, including models, simulations, experimental data, usage studies simulating clinical conditions,
etc.

3.2 DEMONSTRATION OF EQUIVALENCE

Strategy of equivalence
MEDDEV 2.7/1 revision 4 provides an easy to use framework for the appraisal of equivalence based on three basic features:
- Clinical Equivalence:
o Same clinical condition;
o Same intended purpose;
o Same site in the body;
o Similar population;
o Not foreseen to deliver significantly different performances.

- Technical Equivalence:
o Similar design;
o Same conditions of use;
o Similar specifications and properties;
o Similar deployment methods;
o Similar principles of operation and critical performance requirement.

- Biological Equivalence:
o Same materials or substances in contact with the same human tissues or body fluids.

Comparison with potential equivalent device

No equivalent device with enough reliable clinical data was found for the Ligastrap® Malleo brace.

No demonstration of equivalence was done for the MalleoPro Activ brace since clinical data from Thuasne are available (see 3.3.1).

However, an equivalent device was found for the Silistab® Malleo: it is the MalleoTrain® brace from Bauerfeind.

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Table 5: Demonstration of equivalence between Thuasne Silistab® Malleo and Bauerfeind MalleoTrain® ankle orthosis.

Conclusion regarding
Description Silistab® Malleo MalleoTrain®
equivalence *
Manufacturer Thuasne Bauerfeind NA

Picture I

Device class Class I Class I I

Site Ankle region
Ankle support for joint relief
Intended use
and stabilization
- Malleolar protection of
injured or vulnerable joints
- Provides compression to
the ankle during treatment
Clinical conditions – indications
thus enabling early
resumption of physical
activities
- Prevents oedema
Contraindications Not to be used on broken skin
- Elastic ankle brace
- Protective silicone padding
Product characteristics
- Protection of the
malleolus, and instep
Ankle circumference:
Range of products
19 – 33 cm
- Polyester
- Elastane
Composition
- Elastodiene
- Viscose
Ankle region I
Ankle support for joint relief
I
and stabilization
- For Postoperative and
posttraumatic irritation
(e.g. after sprains)
- To reduce/prevent joint
effusions and swellings
(oedema) from
S(1)
osteoarthritis and arthritis
by compression
- Muscle and tendon
disorders
(tendomyopathies)
- Ligamental weaknesses
No contraindications D
- Reduced pressure at the
edges prevents
constriction
- Three-dimensional Train
active knit for a perfect fit
- Viscoelastic pads support
lateral and medial
stabilization of the ankle
and accelerate the
S(2)
absorption of edemas and
effusions
- High elasticity makes the
support easy to put on and
take off
- Breathable Train active knit
gentle on the skin and
extremely comfortable to
wear
Ankle circumference:
S(3)
17 – 29 cm
- Elastodiene
- No other indication on the S(4)
composition was found

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Type of contact (ISO 10993) Surface device – Intact skin Surface device – Intact skin I
Duration of contact (ISO 10993) Limited (<24 hours) Limited (<24 hours) I
Biological effect NA / mechanical effect NA / mechanical effect I
* I: Identical, S: Similarities, D: Different, NA: Non-Applicable.

Discussion about similarities and differences

Thuasne Silistab® Malleo and Bauerfeind MalleoTrain® orthosis are almost identical. The differences between these two devices which are
relatively few are discussed below.

3.2.3.1 Clinical conditions – indications S(1)

The clinical conditions / indications claimed by the manufacturer of MalleoTrain® cover the conditions / indications of the Silistab®Malleo.
MalleoTrain® has just additionally indications compared to the other device such as post-operative support. The use of the MalleoTrain® is
also recommended for physical or sport activities for people with ankle weakness.

3.2.3.2 Contraindications D
There are no contraindications defined for the MalleoTrain® device in the instruction for use (IFU). But it should not be applied on a broken
skin.

3.2.3.3 Product characteristics S(2)

The product characteristics of the 2 devices are almost identical with the pads on the malleolus and their high elasticity. The characteristics
of the Bauerfeind product are just more detailed.

3.2.3.4 Range of products S(3)

The range of products are almost the same but the Thuasne brace takes into account larger ankle circumferences and the Bauerfeind
smaller ankle circumferences. The different sizes of these devices allow to adapt the device to the morphology and the size of ankle’s
patient. This difference doesn’t impact the performance or the safety of the device.

3.2.3.5 Composition S(4)

There are no other indications of the MalleoTrain® composition on the IFU. The only information found on this product is that the inserts
are in elastodiene like the Silistab® Malleo. But when looking for the composition of other Bauerfeind product ranges using knitting, the
composition seems to be almost identical to the Silistab® Malleo brace. Furthermore, the device is not invasive and is only in contact with
healthy skin.

The two devices are considered as equivalent, and clinical data on MalleoTrain® can be used in order to assess the performance and the
safety of the device under evaluation.

3.3 CLINICAL DATA GENERATED AND HELD BY THE MANUFACTURER

Clinical study

3.3.1.1 Scope
The only clinical study generated by Thuasne regards the MallePro Activ brace. It is a comparative study between the Thuasne test device
and the Aircast® ankle-joint prosthetic from DonJoy, used as the standardized reference criterion. A condition with no prosthetic device
was also compared. The aim of the study was to bring clinical evidence of the efficiency of the MallePro Activ brace regarding:

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- Its ability to reduce the severity and speed of a sudden ankle sprain (hypothesis H1);
- Its similarities with the Aircast® ankle-joint prosthetic concerning:
o The reduction of the sprain (H2);
o The combined neurophysical effect (H3);
o The stabilizing effect (H4);
o The wearing properties and fit (H5).

3.3.1.2 Method
A total of 50 patients drawn from a cohort of sports students with an ankle-joint injury were included in this study (18 male and 32 female).
An apparatus which simulates a sprain-induced movement was used. It consisted of a standing grid which could be released by the mean
of an electromagnetic locking system (Figure 3). This apparatus has allowed to record the severity and the speed of ankle-joint movements
(plantar flexion and inversion) with precision. Two conditions were tested with the platform for each ankle orthosis:
- A standard simulation with a 30° inversion;
- A combined simulation with a 30° inversion and a 15° plantar flexion.

Five trials were performed for each condition (platform and brace) to realize an averaging. Subjects were given a standard universal sports
shoe, with a good fit for adaptation to trial conditions.

The measured scores were related to the perceptions and experiences from the subjects regarding the stabilization properties, wearing
comfort and constraints on performance of the two devices. The Visual Analog Scale (VAS) was used for this purpose. The Achilles-tendon
angle and movement (maximum inversion angle, maximum relative inversion angle, angle time trajectory, integrated electromyography,
neuromuscular quotient and total angle) were also recorded thanks to goniometers.

Figure 3: Simulating apparatus of a sprain-induced movement

3.3.1.3 Results and discussion

The maximum inversion angle in a simulated sprain trauma is significantly reduced for the Aircast® ankle-joint prosthetic compared with
no orthosis, but only from a few degrees for the Thuasne brace. The difference obtained with and without orthosis are statistically
significant. There is still a clear difference in the reduction of sprain movement at the ankle joint between Thuasne test model and DonJoy
standard device. The hypothesis H2 is then wrong.

The Thuasne test model reduced the inversion rate by 60°/sec for the standard stimulus and by 70°/sec for the combined stimulus. The
DonJoy standard model reduced the inversion rate by 230°/sec for the standard stimulus and by 250°/sec for the combined stimulus. The
extent and speed of sudden sprain movement was significantly reduced with the Thuasne test model. The hypothesis H1 is then validated.

There was a statistically significant difference for the combined neurophysical effect between Thuasne test device and Donjoy standard
model. The hypothesis H3 is then wrong.

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The comparative subjective analysis of stabilization showed clear differences between the two devices, in favor of the DonJoy standard
device. The hypothesis H4 is then wrong.

However, in what concerns the perceptions and experiences from the subjects regarding the wearing comfort and fit, it was demonstrated
that the Thuasne test device had better scores compared with the DonJoy standard device. The hypothesis H5 is then wrong.

3.3.1.4 Conclusion
The difference favoured the DonJoy standard prosthetic device in respect of stabilising effect but was in favour of the Thuasne test model
where wearing comfort is concerned.

Vigilance

There is no vigilance case regarding Silistab® Malleo and MalleoPro Activ braces reported to the authorities since 2013.

There is only one case of vigilance reported to the authorities since 2013 regarding the Ligastrap® Malleo brace.

Table 6: Vigilance case regarding the Ligastrap® Malleo brace.

Ligastrap® Malleo
Year
Notifier Description of injury(ies) Corrective action Notification to health authorities

2017 Thuasne UK Allergic reaction Unknown Unknown

This case is an allergic reaction due to the use of Ligastrap® Malleo brace. No more details have been given. The vigilance file is available
in Appendix A – Device documentation.

Complaints

Complaints regarding Ligastrap® Malleo, Silistab® Malleo and MalleoPro Activ braces are summarized in the following table.

Table 7: Nature of complaints for Ligastrap® Malleo, Silistab® Malleo and MalleoPro Activ braces.

Year Ligastrap® Malleo Silistab® Malleo MalleoPro Activ

2017 Total: 105
- 8 because of their aspect
- 12 because the scratch band
- 3 for unknown reason
- 29 because of the seam/weld
- 1 because the brace did not fit
- 28 because of the finishing
- 12 with no visible defect
- 12 because of a hole
2018 Total: 132
- 1 because of the anti-slip
- 10 because of their aspect
- 12 because the scratch band
- 6 for unknown reason
- 20 because of the seam/weld
- 1 because the brace did not fit
Total: 4
- 3 because their aspect
- 1 with no visible defect
Total: 16
- 3 because of their aspect
- 1 for unknown reason
- 2 because of the seam/weld
- 1 because of the finishing
- 3 with no visible defect
- 6 because of a hole
Total: 13
- 3 because their aspect
- 1 for unknown reason
- 6 because of the seam/weld
- 3 with no visible defect
Total: 11
- 2 because of their aspect
- 4 because of the seam/weld
- 4 with no visible defect
- 1 because of a hole

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Year Ligastrap® Malleo Silistab® Malleo MalleoPro Activ

- 29 because of the finishing
- 33 with no visible defect
- 20 because of a hole

A total of 237 complaints were reported for the Ligastrap® Malleo, 20 for the Silistab® Malleo and 24 for the MalleoPro Activ between
2017 and 2018. The causes of these complaints are due to the scratch band, the seam or other defect of manufacturing process.

The complaints file is available in Appendix A – Device documentation.

3.4 LITERATURE REVIEW ON EQUIVALENT DEVICE

Only two articles related to the MalleoTrain® were found on Google scholar, PubMed and ScienceDirect. This research was realized the 18th
of June 2019. The selected articles are used here to assess the performance and safety of the Silistab®Malleo.

Table 8: Articles related to the equivalent device MalleoTrain

ID Title
O’Hara 1992 Controlled trial of an ankle support (Malleotrain) in acute ankle injuries
Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in
Kuni 2015
healthy subjects and subjects with chronic ankle instability

The aim of the first article (O’Hara 1992) was to evaluate the use of MalleoTrain® in the treatment of patients with acute ankle injuries. A
total of 220 patients with a mean age of 35.2 years were included to this study (153 men and 67 women). On these 220 patients, 118 were
treated with the MalleoTrain® brace and 102, the control group, received therapy advice on resting the affected joint and a simple bandage.
The main pathology diagnosed were with acute ankle injuries, unassociated with bony injury or major ligamentous damage. Scores such as
pain (Visual Analog Scale), limitation of activity, ability to work, comfort, ease to use and improvement were recorded for 2 weeks. It
appeared that pain improvement was greater in the group on MalleoTrain® brace. This brace resulted in more rapid alleviation of
symptoms than did the simple bandage and is acceptable to patients. Analgesic consumption was consistently lower with the bracing
group. MalleoTrain® is therefore recommended in the management of all patients with such injuries.

The second study (Kuni 2015) purpose was to compare kinesiotape with non-elastic tape and a soft brace (MalleoTrain®) with respect to
their effects on segmental foot kinematics during drop landing in patients with chronic ankle instability (CAI) and healthy subjects. A total
of 40 patients with a mean age of 25.5 years (9 men and 11 women) were recruited for the study. On these 40 subjects, 20 were healthy
and 20 had CAI. All the patients were tested under 4 conditions: barefoot, with NASARA Kinesiology Tape, with Leukotape non-elastic tape
(BSN Medical) and with the MalleoTrain® brace (Bauerfeind). Rearfoot excursion, inclination of the medial arch, and dorsi-/plantarflexion
in the tibiotalar joint were determined. In both groups, the rearfoot excursion in eversion/inversion was significantly lower in the non-
elastic tape and brace conditions than in the barefoot condition, whereas the differences compared with the kinesiotape condition were
not significant. Kinesiotaping, non-elastic taping and bracing reduced the maximum plantarflexion in landing compared with the barefoot
condition. Soft braces have a quantitative effect on talocrural and rearfoot kinematics. However, in patients with CAI, non-elastic taping
provided additional stability in the midfoot.

To conclude on the use of the MalleoTrain® orthosis, it was demonstrated that pain and limitation of activity were reduced and ability to
work was improved. It was also shown that this brace is quite comfortable and easy to use. Compared to other support such as taping, the
MalleoTrain® has a quantitative effect on ankle joint kinematics. However, stability in the mid-foot is better with a non-elastic taping. Thus,
the MalleoTrain® is quite effective for ankle joint relief and stabilization.

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4 CONCLUSIONS
The literature review related to the Silistab® Malleo allowed to demonstrate the performance and the safety of the device under evaluation.
Indeed, ankle joint relief and stabilization were proved with the use of ankle brace. Additionally, regarding the ratio between the total
number of complaints between 2017 and 2018 (20) and the amount of Silistab® Malleo orthosis sold by Thuasne (23 076), the rate of
complaints is largely negligible (0.09 %). Moreover, no vigilance cases were reported. Thus, the safety of the device is demonstrated.

In what concerns the Ligastrap® Malleo, no clinical data were generated by Thuasne nor clinical data for an equivalent device were found.
It is thus advised to set up a Post-Market Clinical Follow-up on these devices. The PMCF plan will be attached to the PMS plan of these
products. Regarding the ratio between the total number of complaints between 2017 and 2018 (237) and the amount of Ligastrap® Malleo
orthosis sold by Thuasne (211 647), the rate of complaints is largely negligible (0.11 %). Similarly, the number of vigilance cases reported
(1) is extremely low (0.0005 %). Thus, the safety of the device is demonstrated.

Finally, for the MalleoPro Activ brace, clinical study related to this device did not allowed to demonstrate the performance and the safety
of the devices under evaluation. That is why it is advised to set up a Post-Market Clinical Follow-up on this device. The PMCF plan will be
attached to the PMS plan of these products. Moreover, regarding the ratio between the total number of complaints between 2017 and
2018 (24) and the amount of MalleoPro Activ orthosis sold by Thuasne (13 677), the rate of complaints is largely negligible (0.18 %).
Furthermore, no vigilance cases were reported. Thus, the safety of the device is demonstrated.

The data available confirms

- Compliance to the essential requirements of MDD ER1 ER3 ER6
- Acceptability of the benefit/risk profile according to current knowledge/ the state of the art in the medical fields concerned and
according to available medical alternatives.

5 DATE OF NEXT CLINICAL DATA

The clinical evaluation must be redone every 5 years except under particular circumstances (scope change, new data regarding the risk-
benefit balance …). The date of the next clinical evaluation is then June 2024.

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6 DATES AND SIGNATURES

See Appendix D and Appendix E for the detailed list, choice of evaluators and declaration of interests.

Declaration of the evaluator Date - Signature

Justine CARPENTIER, Technical Manager in Clinical and Regulatory Affairs,

AlisPharm, evaluator of the present report do hereby agree with its content and its
conclusions. My declaration of interest in the context of this evaluation is attached.

Adeline PALLEZ, Clinical Evaluation Manager, THUASNE, evaluator of the present

report do hereby agree with its content and its conclusions.

Final release by the manufacturer

Name of the manufacturer’s representative Date - Signature

Carole ROBIN, Regulatory Affairs Director, THUASNE, evaluator of the present

report do hereby agree with its content and its conclusions.

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LIST OF APPENDICES

Appendix A: Device documentation

Appendix B: Search Report
Appendix C: Publications
Appendix D: Qualification of evaluator
Appendix E: Declaration of interest of evaluator

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