CLINICAL EVALUATION REPORT

Knee Orthoses

version 1.0

THUASNE
120 rue Marius Aufan
CS10032
92309 Levallois-Perret Cedex
FRANCE
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TABLE OF CONTENTS
Table of Contents ......................................................................................................................... 2

1 Scope of the clinical evaluation ............................................................................................ 3

1.1 Introduction............................................................................................................................................3
1.2 Description of the devices...................................................................................................................3
General description ..........................................................................................................................3
Device group ......................................................................................................................................4
Intended purpose of the device s .................................................................................................4
Intended performance and claims ...............................................................................................4
1.3 Demonstration of equivalence ..........................................................................................................4
2 Literature Search ................................................................................................................... 6

2.1 edical fields concerned and relevant medical conditions. ...........................................................6

2.2 Documents search Methodology ......................................................................................................6
Databases ...........................................................................................................................................6
Main Keywords and Combinations ...............................................................................................7
Period ..................................................................................................................................................8
Search Results ...................................................................................................................................8
2.3 Summary of clinical evidence .............................................................................................................8

3 Device under Evaluation ....................................................................................................... 8

3.1 Type of evaluation ................................................................................................................................8

3.2 Clinical data generated and held by the manufacturer ...............................................................9

4 Conclusions ............................................................................................................................ 9

5 Date of next clinical evaluation ............................................................................................ 9

6 References .............................................................................................................................. 9

7 Dates and signatures ........................................................................................................... 10

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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 DEVICES

General description

1.2.1.1 Names:

1) Ligaflex Immo
2) Ligaflex Immo junior
3) Genuimmo

1.2.1.2 Main components / models / sizes

Ligaflex Immo: sizes S–M–L–XL.

Short / Long.
0° / 20°.
Genuimmo: sizes S–M–L–XL.
Short / Long.
0° / 20°.

The devices do not use any accessories.

The devices do not use/incorporate any software or medicinal substance.
The devices are reusable.
The devices are non-sterile.

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1.2.1.3 Identification of the manufacturer

Name of Manufacturer: Thuasne

Address: 120 rue Marius Aufan
CS10032
92309 Levallois-Perret Cedex
FRANCE

Device group

Knee orthoses.

Intended purpose of the device s

Devices are intended for a knee fixation and support.

Intended performance and claims

1.2.4.1 Technical performances intended by the manufacturer

The manufacturer assumes sufficient longevity of the device when used, washed, and treated by the patient
according to the instructions for use.

1.2.4.2 Intended clinical benefits and Claims regarding clinical performances

The manufacturer assumes a relevant benefit to the patient due to efficiency of the medical device in health
conditions improvement in relation to indications listed in the instructions for use.

1.2.4.3 Claims regarding clinical safety

The manufacturer assumes high safety of the medical device without any real health risk to the patient when used
in accordance with the intended purpose, taking into account the nature and risk class of the medical device.

1.3 DEMONSTRATION OF EQUIVALENCE

As equivalent, the knee orthoses of the manufacturer “Allard Support UK Ltd.” can be used. An equivalency test is
carried out in Table 1.
Table 1: Equivalence test

ALLARD KNEE
Aspects Parameter THUASNE KNEE ORTHOSES
ORTHOSES
Use under the same clinical Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
conditions (same KNEE ORTHOSES have the same use for the same
indications) indications. These medical devices are indicated after
Clinical

injuries and other pathological states in the knee area.

Specified purpose of use Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES are intended for knee fixation and
stabilization.

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The same place of use on
the body
Usage for the same
population (age, gender,
anatomy, etc.)
Different clinical results
cannot be expected
The result of clinical
equivalence
Similar design
Use the same way
Similar specifications and
Technical
properties (physical and
chemical properties)
Similar functioning principle
and similar critical functional
requirements
Results of technical
equivalence
Use of the same materials in
contact with human tissues
Biological
Results of biological
equivalence
Based on the equivalence test in Table 1, it can be stated that the assessed medical devices THUASNE KNEE
ORTHOSES and medical devices ALLARD KNEE ORTHOSES are equivalent on the basis of clinical, technical and
biological properties and this conclusion can be drawn:
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Clinical Evaluation Report
Medical devices “THUASNE KNEE ORTHOSES" and ALLARD
KNEE ORTHOSES are coming into the contact with the
patient’s intact skin.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES both can be applied regardless age and
gender.
Due to the similarity of the intended use, application and
indication of medical devices “THUASNE KNEE ORTHOSES”
and "ALLARD KNEE ORTHOSES" cannot be expected to
provide different clinical results.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES are clinically equivalent.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES have a very identical design, i.e. orthoses.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES are used in the same way, i.e. by wearing
on lower limb.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES have similar specifications and
properties.
Medical Devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES have the same principle of functioning.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES are technically equivalent.
Medical Devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES might not have the same composition in
contact with human tissues – composition might differ
between the devices. However, this difference is justified
by only coming into contact with intact skin of patient, and
using of biocompatible materials in contact with human.
Therefore, according to MEDDEV 2.7/1 rev. 4, the
difference is acceptable.
Medical devices “THUASNE KNEE ORTHOSES” and ALLARD
KNEE ORTHOSES are biologically equivalent.
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Medical devices “THUASNE KNEE ORTHOSES” are equivalent to the medical devices ALLARD KNEE ORTHOSES and
clinical data obtained from their clinical application can be used for the clinical evaluation of the medical devices
under evaluation.

2 LITERATURE SEARCH

2.1 EDICAL FIELDS CONCERNED AND RELEVANT MEDICAL CONDITIONS.

Knee orthoses – braces can be classified to:

o Prophylactic knee braces – designed to prevent or reduce the severity of knee injuries. The basic design for
these braces has not changed much over the years. They include some type of lightweight lateral bar with
single, dual, or polycentric hinges with hyperextension stops. The braces are attached via tape, sleeves, or
straps.
o Functional knee braces – designed to provide stability for unstable knees. Currently there are more than
20 varieties of functional knee braces.
o Rehabilitative knee braces – designed to allow protected range of motion for injured knees after surgery
or other treatment1.
The decision whether to indicate a knee brace to a patient after surgical reconstruction of the anterior cruciate
ligament remains with the physician in the context of patient individuality and treatment goals. Clinical evidence
supports the use of orthosis immediately after surgery to maintain full range of motion and reduce exudate.
However, it is possible that targeted physical therapy can achieve the same results. The orthosis can also play an
important psychological role, especially in the case of returning to sport2.

Levy et al. in their study made recommendations to doctors deciding on how to treat multiple knee ligaments
injuries. In case of arterial injury or open knee dislocation, reconstructive surgery is required followed by standard
rehabilitation and monitoring. Otherwise, the first method of treatment is the knee brace, and only in the event of
an orthosis or plate mobilization failure an operative solution takes place3.

2.2 DOCUMENTS SEARCH METHODOLOGY

Databases

The scientific literature was searched using the database PubMed and key words presented below.

Web medical base PubMed4 is a database recommended as a reliable source of scientific data. PubMed comprises
more than 63 million citations for biomedical literature from MEDLINE, life science journals, and online books.
PubMed citations and abstracts include the fields of medicine, nursing, dentistry, veterinary medicine, the health

1 SCRIBER, Kent. The History and Current Use of Knee Brace Technology. Athletic Therapy Today. 1998, 3(4), 7-11
2 MASINI, Brendan D. and Brett D. OWENS. Current Recommendations for Anterior Cruciate Ligament Bracing:
When to Use. The Physician and Sportsmedicine. 2015, 41(1), 35-39
3 LEVY, Bruce A et al. Staged protocol for initial management of the dislocated knee. Knee Surgery, Sports

Traumatology, Arthroscopy. 2010, 18(12), 1630-1637

4 http://www.ncbi.nlm.nih.gov/pubmed

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care system, and preclinical sciences. PubMed also provides access to additional relevant Web sites and links to the
other NCBI molecular biology resources. PubMed is a free resource that is developed and maintained by the
National Center for Biotechnology Information (NCBI), at the U.S. National Library of Medicine (NLM), located at
the National Institutes of Health (NIH).

Main Keywords and Combinations

The collection and identification of data for this section has been achieved by scientific literature searching. The
aim of searching was to retrieve clinical data relevant to the medical device. Both desirable and undesirable data
were used to avoid any bias.

The scientific literature was searched using the key words: knee AND (orthosis OR brace) AND fixation.

Figure 1: Methodology of searching study

The keyword selection process was based on the flowchart (Figure 2: Keyword Selection).

Figure 2: Keyword Selection

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Period

Literature was searched on 16th of June 2019. The period of publication dates was set at 10 years.

Search Results

Table 2: Search Results

Studies Studies
Database Keywords Filters Reference
found used
knee AND (orthosis OR brace) Humans,
PubMed 58 6 [1–6]
AND fixation 2009–2019

2.3 SUMMARY OF CLINICAL EVIDENCE

The first randomized clinical trial evaluated the subsequent fixation of the knee dislocation after ligament
reconstruction using the Compass Knee Hinge knee brace (invasive external metal fixator) compared to the orthosis.
The orthosis showed slightly better clinical results [1].

The next clinical study was focused on patients with knee osteoarthritis. Knee brace was used for treatment. The
pain according to VAS (visual analogue scale) was evaluated separately and the KOOS questionnaire was completed.
Patients experienced a statistically significant improvement after 6 weeks of treatment, in all of the measured
outcomes [2].

Clinical study involving 204 patients who used two different types of knee braces also showed a similarly high
improvement in all of the clinical outcomes studied [3].

Another study dealt with the reconstruction of the anterior cruciate ligament. The results of the study confirmed
the safety of the elevation exercise of the lower limbs after reconstruction of the anterior cruciate ligament during
the knee brace using [4].
Clinical study examined the treatment of acute knee dislocation of Schenck III and IV types. A reconstructive
operation should be performed for a maximum of 7 days after the injury. As a postoperative treatment in this study,
a Hypex-Lite® (Albrecht) knee stabilization brace was selected for 12 weeks. This treatment procedure showed good
results. In two cases, a flexion deficit was observed during the follow-up [5].

Subacute and chronic instability patients with multiple ligament injuries were randomly divided into two groups.
The control group was indicated by knee brace after surgery and an external fixator was introduced in the
experimental group. The external fixator provided the same ligament stability and improved range of motion after
the treatment. However, this is at the expense of invasive treatment [6].

3 DEVICE UNDER EVALUATION

3.1 TYPE OF EVALUATION

The clinical evaluation is performed on the basis of demonstration of equivalence and scientific literature review
regarding use of knee orthoses, their effectiveness and safety.

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3.2 CLINICAL DATA GENERATED AND HELD BY THE MANUFACTURER

There is no clinical data generated and held by the manufacturer. Pre-clinical data and risk management data are
available as part of the technical documentation of the manufacturer.

4 CONCLUSIONS
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 EVALUATION

The date of the next clinical evaluation is May 2020.

6 REFERENCES
[1] STANNARD, James P. et al. Hinged External Fixation in the Treatment of Knee Dislocations. The Journal of Bone
& Joint Surgery. 2014, 96(3), 184-191.

[2] ORNETTI, P. et al. Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee
osteoarthritis. Annals of Physical and Rehabilitation Medicine. 2015, 58(3), 126-131.

[3] YU, Shirley P. et al. Effectiveness of knee bracing in osteoarthritis: pragmatic trial in a multidisciplinary
clinic. International Journal of Rheumatic Diseases. 2016, 19(3), 279-286.

[4] MAE, Tatsuo et al. In Vivo Graft Tension in Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction
During Active Leg-Raising Motion with the Knee Splinted. Arthroscopy: The Journal of Arthroscopic & Related
Surgery. 2012, 28(4), 532-538.

[5] HEITMANN, M. et al. Ligament bracing – Augmentierte Primärnaht bei multiligamentären Verletzungen des
Kniegelenks. Operative Orthopädie und Traumatologie. 2014, 26(1), 19-29.

[6] ANGELINI, Fabio Janson et al. External fixator for treatment of the sub-acute and chronic multi-ligament-injured
knee. Knee Surgery, Sports Traumatology, Arthroscopy. 2015, 23(10), 3012-3018.

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Name: Petr Votava
1. Education:
2012–2015, Czech Technical University, Faculty of Biomedical Engineering, Radiology
Assistant.
- Bachelor theses: “Evaluation of doses outside the target volume at localised prostate
cancer”.
2015–2017, Czech Technical University, Faculty of Biomedical Engineering, Systematic
Integration of Processes in Health Service.
- Master theses: “Evaluation of the safety and quality of new therapeutics devices when
entering a market” – focused on medical devices legislation in EU, ISO and IEC
standards, and health technology assessment (HTA).
2. Courses:
2017, Neurophotonics of Vision course on Universidad Politécnica de Madrid.
3. Professional experience:
2016–2017, Radiology Assistant, Medica JM s.r.o.
- Performing radiologic procedures to provide radiologists x-ray diagnostic images to
assess.
2017, Specialist of Supply and Purchase, General University Hospital in Prague.
- Coordination of preparation and realization of investments in health technologies
field. Coordination of purchasing of consumables and minor assets. Checking the legal
placement of purchased medical devices on market. Performing market research.
Negotiating with suppliers and HCP to achieve reasonable spending of resources.
2017–2019, Regulatory Affairs Consultant, Porta Medica s.r.o.
- Performing clinical evaluations, risk analysis, technical documentations of medical
devices. Experience in quality management system. Statistical processing of data.
Reimbursement application of healthcare procedures. Consultancy in healthcare field
and related legislation and normalization.