SMS Rapport-Investigation-Clinique 20230221 V1.0 PDF

Rapport d’Investigation Clinique
Version 1.0 – PMCF_SMS_01
CLINICAL INVESTIGATION REPORT
« RETROSPECTIVE STUDY EVALUATING THE PERFORMANCE AND SAFETY

OF THE SMS BIORESORBABLE INTERFERENCE SCREW »
« PMCF_SMS_01 »
Identification
N°HDH: N° F20221108130730
Protocol reference: PMCF_SMS_01
Date: 21/02/2023
Version: 1.0
Sponsor
Sponsor : DEDIENNE Santé

Address: Le Mas des Cavaliers, 217 rue Nungesser, 34130 Mauguio, France
Telephone: +33 (0)4 66 28 06 85
Coordinating/Principal Investigator
Name Coordinating/Principal investigator: Dr MEYER Alain
Title: Orthopaedic surgeon
Address: Institut de chirurgie orthopédique de Paris (CDS – Chirurgie du Sport) Clinique du Sport, 36
Boulevard Saint-Michel - 75005 Paris
Phone: 01 40 79 40 32
CRO/consultant
na
Scientific committee
na
This report was written by: Matthieu MERLOT
Confidentiel Page 1 sur 23

Document Qualité - Propriété DEDIENNE Santé - Reproduction interdite
FOR_REG_040 – Ind.A – Date Application : 20/05/2021
Plan d’Investigation Clinique
SIGNATURE PAGE
Sponsor’s representative Signature
Date: 21/02/2023
Mr.Ludovic TOLEDO
General Director, DEDIENNE-Santé
Visa:
Mr.Matthieu MERLOT
Date:21/02/2023
Clinical Project Manager, DEDIENNE-Santé
Writer of the present clinical investigation report.
Visa:
Date:21/02/2023
Mrs.Marion BURLAND
Clinical Affairs Manager, DEDIENNE-Santé
Visa:
Coordinating/Principal investigator Signature
Dr MEYER Alain, Orthopaedic Surgeon Date:

principal investigator and external evaluator, agree with
content of the present clinical investigation report. Visa:
Confidential Page 2 sur 23

Tables and Figures
TABLES
Table 1 : SMS Screw range devices ................................................................................................... 9
Table 2 : Clinical performances, safety and benefits of the devices under evaluation ........... 9
Table 3 : Preoperative demographic data ....................................................................................... 14
Table 4 : Preoperative clinical score ................................................................................................. 16
Table 5 : Per operative data ............................................................................................................... 16
Table 6 : SMS Screw size distribution .............................................................................................. 17
Table 7 : Description of re-operated patients ................................................................................ 18
Table 8 : Results of functional clinical scores at 1-year post-surgery ...................................... 18
Table 9 : Lysholm and Tegner score at 1-year post-surgery. .................................................... 19
Table 10 : ACL-RSI score at 1-year post-surgery ......................................................................... 19
Table 11 : Return to sport at 1-year post-surgery for all patients. ........................................... 20
Table 12 : Return to sport at 1-year post-surgery for professionals & competitors. ............ 20
FIGURES
Figure 1 : Rupture of the anterior cruciate ligament ...................................................................... 7
Figure 2 : SMS Screw implantable devices ....................................................................................... 9

SOMMAIRE
1 Summary .......................................................................................................................................... 6
2 Introduction .................................................................................................................................... 7
3 Investigational device and methods .................................................................................... 8

3.1 Investigational device description 8
3.1.1 Manufacturer identification .................................................................................................. 8
3.1.2 CE-marking history / Device Status .................................................................................. 8
3.1.3 Device description .................................................................................................................. 8
3.1.4 Intended use ........................................................................................................................... 9
3.1.5 Description of clinical performance .................................................................................... 9
3.1.6 Changes to the investigational device ............................................................................. 10
3.2 Clinical investigation plan 11

3.3 Ethics considerations 13
3.4 Administrative structure of clinical investigation 13
4 Results ............................................................................................................................................ 14
4.1 Initiation date 14

4.2 Completion date 14
4.3 Disposition of subjects 14
4.4 CIP compliance 14
4.5 Demographic and preoperative data 14
4.5.1 Demographic data at first surgery ................................................................................... 14
4.5.2 Clinical score ......................................................................................................................... 15
4.5.3 Peroperative data ................................................................................................................. 16
4.5.4 Medical Device – SMS Screw used. .................................................................................. 17
5 Data analyses ............................................................................................................................... 17
5.1 Clinical performance and Safety 17

5.1.1 Safety Assessment – Primary objective .......................................................................... 17
5.1.2 Safety Assessment – Secondary objective ..................................................................... 17
5.1.3 Performance Assessment - restoration of joint function ............................................. 18
5.1.4 Performance Assessment - resumption of daily physical activity. ............................ 19
5.1.5 Performance Assessment – Return to physical activity. ............................................. 19
5.1.6 Adverse Events Assessment .............................................................................................. 21
5.2 Device malfunction 21

5.3 Subgroup analyses 21
5.4 Missing data handling 21
5.5 Additional analyses 21
5.6 Patient’s deaths or lost to follow-up. 21
6 Discussion and conclusion ...................................................................................................... 23

Abbreviations and Definitions
ACL Anterior Cruciate Ligament
AE Adverse Event
BMI Body Mass Index
CRF Case Report Form
FU Follow-up
IKDC International Knee Documentation Committee
KOOS Knee Injury and Osteoarthritis Outcome Score
MD Medical Device
NA Not Applicable
PI Principal Investigator
PMCF Post Market Clinical Follow-up
QOL Quality of Life
SAE Serious Adverse Event
SMS Screw SMS Bioresorbable Interference Screw

1 Summary
Title Retrospective study evaluating the performance and safety of the SMS Bioresorbable
Interference Screw
Introduction The SMS Bioresorbable Interference Screw is a class III implantable medical device,
first marketed in 2013. It is intended to be used in an adult population for fixation of soft
tissue grafts or bone-tendon grafts (autograft) in the tibia and/or femur during initial
ACL reconstruction surgery with or without meniscal injuries, in order to relieve pain
and restore joint function.
The SMS Bioresorbable Interference Screw is a fully threaded, cannulated and

resorbable fixation device that provides mechanical fixation in ACL reconstruction. It is
available in several diameters (6-11 mm) and three lengths (23, 30 and 35 mm). The
material of the SMS resorbable interference screw is biocompatible. It is the resorbable
co-polymer poly (l-lactide-co-D, L-lactide) formed from PLLA and PDLLA with a 70/30
ratio. This polymer is degraded in-situ by hydrolysis generating lactic acid which will be
metabolised by the body.
Purpose This retrospective study was conducted on the SMS Bioresorbable Interference Screw.
Population The retrospective study was conducted on an adult, athletic population requiring initial
ACL reconstruction with or without meniscal lesions with sufficient bone maturity or
density between 1 January 2018 and 31 September 2021.
Methodology Quantitative variables have been summarised with position indicators (mean and
median), dispersion indicators (corrected standard deviation, 1st and 3rd quartile,
minimum and maximum), a confidence interval (if relevant), the number and
percentage of missing data.
Qualitative variables were described with the number and percentage of each modality,
a confidence interval associated with each percentage (if relevant), the number and
percentage of missing data.
The number of patients was estimated and also presented in each result table.
Confidence intervals are two-sided and have been given with a 5% alpha risk.
Demographic and clinical data of the included population and surgery as well as
endpoints and safety data were presented using standard descriptive statistics.
Statistical methods and analyses may evolve as needed: subgroup analyses (e.g.
groups with different surgical techniques) may be performed for specific publications
or regulatory requirements.
Results See paragraph 4 & 5
Conclusion All objectives have been evaluated and demonstrated. The performance and the safety
of the medical device SMS (Bioresorbable Interference Screw) are validated.
Initiation date October 2022
Completion date February 2023

2 Introduction
The anterior cruciate ligament (ACL) is a ligament located in the centre of the knee joint. It plays an
essential role in the stability of the knee, particularly in rotational movements of the knee. The ACL
opposes internal rotation of the tibia relative to the femur and excessive internal rotation can lead to ACL
rupture. Without the anterior cruciate ligament, the knee is no longer stable and becomes unstable and/or
painful. The persistence of this instability can be responsible for the development of meniscus damage
and premature wear of the knee cartilage leading to early osteoarthritis. Once ruptured, the anterior
cruciate ligament cannot heal on its own.
Figure 1 : Rupture of the anterior cruciate ligament
ACL rupture is one of the most frequent and serious knee injuries. They are particularly frequent in sports
traumatology, mainly in pivot sports: football, handball, basketball, rugby, skiing, etc.... 35,000 ruptures
were operated on per year in France in 2007, i.e. We observed 1 per 1900 inhabitants (ATIH, 2007 1). The
number of ACL reconstructions has been steadily increasing over the last twenty years (58% increase
between 1994 and 2013 in the USA). There are still disparities between the sports disciplines concerned
by this type of incident. According to SIGASCOT Sports committee, the return to sport for non-contact
sports is at 6 months post-operatively, 87% of patients return to the field and only 48% to competition.
For contact sports, the rates decrease to 53% and 13% respectively 2.
Surgical treatment with ligament replacement is the most common option, stabilising the knee and
preventing instability, but not preventing progression to osteoarthritis. The human impact of an ACL
rupture is not only physical, but also socio-economic in terms of primary (care, time off work) and
secondary (long-term care and disability from gonarthrosis) costs, and a significant psychological and
physiological impact.3
The aim of this study was to meet regulatory requirements for post-market clinical follow-up and to
improve the state of knowledge on the performance and safety of the SMS Bioresorbable Interference
Screw. Retrospective clinical data were collected in routine clinical practice from the database managed
by Dr MEYER and analysed. The patients had given their written consent for the use of their data in data
processing such as ours.

This analysis allowed us to better define the contours and to better understand the performance and
safety of the medical device, even if these elements had already been widely anticipated.
Due to the retrospective and non-interventional nature of this study, no direct benefit was expected for
the people who took part in the study. Similarly, there was no expected risk associated with participation
in the study as only data available in the computerised patient records were analysed.
References:
1. ATIH: Agence technique de l’information sur l’hospitalisation. https://www.atih.sante.fr/.
2. SIGASCOT Sports Committee et al. Return to sport after ACL reconstruction: a survey between the
Italian Society of Knee, Arthroscopy, Sport, Cartilage and Orthopaedic Technologies (SIGASCOT)
members. Eur J Orthop Surg Traumatol 26, 509–516 (2016).
3. Tamalet, B. & Rochcongar, P. Épidémiologie et prévention de la rupture du ligament croisé antérieur
du genou. Revue du Rhumatisme Monographies 83, 103–107 (2016).
3 Investigational device and methods
3.1 Investigational device description
3.1.1 Manufacturer identification
DEDIENNE Santé
Le Mas des Cavaliers
217 rue Nungesser
34130 MAUGUIO
France
Phone: +33 (0)4 66 28 06 85
E-mail: contact@dedienne-sante.com
Website: https://www.dediennesante.com
3.1.2 CE-marking history / Device Status
Devices under evaluation are currently CE Marked. SMS Screw range have been first CE marked and
marketed from April 2013 to January 2015 (EC Certificate N°1344842-00 / CE 0499), from January 2015
to March 2017 (EC Certificate 1344842-01 / CE 0499), from March 2017 to March 2018 (EC Certificate
N°34066 / CE 0459) and from March 2018 to April 2018 (EC Certificate N°32779 / CE 0459), and are CE
marked since August 2020 (EC Certificate N°184-MDD-20-703 / CE 1984). SMS Screw range devices
have been marketed in France and in various export countries and are currently marketed in France and
Burkina Faso.
3.1.3 Device description

SMS Screware cannulated bioabsorbable interference screws intended for the fixation of soft tissue grafts
or bone-tendon grafts (autograft) of the tibia and/or femur during initial reconstruction surgery on a torn
Anterior Cruciate Ligament (ACL). They are single use devices sterilized. SMS Screw are made from a
bioresorbable 70/30 L-lactide/DL-lactide copolymer (PURASORB PLDL 7060).
Devices of the range SMS Screw are available in two variants: round head (screws of length 23mm) are
designed for tibial fixation while flat head (screws of length 30mm and 35mm) are designed for femoral
fixation:
Figure 2 : SMS Screw implantable devices
These bioabsorbable screws are available in 11 sizes: length 23mm and 30 mm are available in 4
diameter (respectively 6mm to 9mm and 8mm to 11m) and length 35mm is available in 3 diameters (9mm
to 11mm).
Table 1 : SMS Screw range devices
Common name Designation Reference

Bioabsorbable interference screw Ø6 L23mm SMS Screw Ø6 L23 35.BS.0623
3.1.4 Intended use

SMS Screw is intended to be used on adult population in the following medical condition:
• Fixation of soft tissue grafts or bone-tendon grafts (autograft) of the tibia and/or femur during
initial reconstruction surgery on a torn ACL, whether or not associated with meniscus injury.
3.1.5 Description of clinical performance

Table 2 : Clinical performances, safety and benefits of the devices under evaluation

Performances Evaluation
Expected
Claim Type of claim Metric
threshold 1
% Effusion ≤60.0%
Safety profile % Implant breakage ≤9.6%
equivalent to other
☐Performance
bioabsorbable ☒Safety % Infection ≤6.7%
interference screws % Arthrofibrosis, cyclops lesion,
≤5.9%
adhesions
Survival rates in line
☐Performance
with those expected for 0 to 2Yrs: ≤2.5%
☒Safety % of graft revision
initial ACL 2 to 3Yrs: ≤4.5%
reconstruction
KOOS mean value ≥80 points
☒Performance
Restauration of knee IKDC mean value ≥80 points
function ☐Safety Lysholm score mean value ≥65 points
Tegner score mean value ≥4.9 points
Benefits Evaluation
Improvement* of knee score(s) (KOOS, IKDC) from
Functional recovery
baseline
Pain release Improvement* of KOOS-pain score from baseline
*Note1: Improvement is achieved when one of the following conditions is met:

• The post-operative score is significantly better than the preoperative score (assessment done through appropriate
statistical tests),
• The difference between the post-operative score and the pre-operative score is higher than the Minimal Clinically
Important Difference
3.1.6 Changes to the investigational device

Not applicable, no changes were performed on the investigational devices during this clinical
investigation.
1
Expected threshold are based on data retrieved from the State of the Art (See SotA_ACL_Reconstruction_20230228 –).

3.2 Clinical investigation plan
N° Primary objective Primary endpoint

To evaluate whether the use of Evaluation of the of the success
SMS absorbable interference of the surgery via the rate of
screws is effective for the medium-term revision (within
the first 12 months following the
fixation of soft tissue grafts or
1 surgery) whatever the cause.
bone-tendon grafts (autograft)
in the tibia and/or femur during
initial ACL reconstruction
surgeries at 1-year post-op.
N° Secondary objectives Secondary endpoints

To evaluate whether the use Evaluation of the of the success
of SMS resorbable of the surgery via the rate of
interference screws is medium-term revision (within
effective for fixation of soft the first 36 months following the
2 tissue grafts or bone-tendon surgery) whatever the cause.
grafts) in the tibia and/or
femur in a subgroup of
Objectives patients with 3 years of follow-
up.
Determine whether the use of Assessment of restoration of
SMS absorbable interference joint function (performance)
screws contributes to the using the KOOS questionnaire
3
restoration of joint function. at 1-year post-op and the IKDC
questionnaire at 1-year post-
surgery.
Determine whether the use of Assessment of recovery of daily
SMS absorbable interference activity by the Lysholm and
4 screws contributes to the Tegner scales at 1-year post-
return to daily activities. surgery.
To determine whether the use Collection of all evidence to
of SMS absorbable demonstrate a return to sport.
5 interference screws impacts
psychological factors on
return to sport.
Safety assessment of SMS Collection of all adverse events
6 bioresorbable interference and effects.
screws.
Single-centre, retrospective, non-interventional study not directly involving

Design humans.

National Commission on Informatics and Liberty

Reference methodology: MR004
Due to the retrospective nature of the study, this project was not submitted to
Ethical consideration any Ethical Committee. However, in accordance with the regulations, the
study PMCF_SMS_01 has been declared on the French public register of the
Health Data Hub (HDH).
Data quality No monitoring activities during the case report form completion. All data have
assurance been checked at the end of the input.
Adult sports population requiring initial ACL reconstruction with or without

meniscal injuries with sufficient bone maturity or density. 220 patients were
included in this study.
The following selection criteria were used.
N° Inclusion criteria Non-inclusion criteria

Male or female, 18 years of Patients who objected to their
age or older, data being used outside their
1
medical care
Sports patients who have Patients whose clinical follow-up

been managed by Dr. Meyer cannot be performed (deceased,
Subject population for anterior cruciate ligament lost to follow-up...).
reconstruction using one or
more SMS bioresorbable
2 interference screws
regardless of the surgical
technique used between
January 1, 2018, and
September 31, 2021.
Patient who has agreed to the

use of their data for research
3
purposes.
Due to its retrospective nature, no additional procedures have been

implemented in this study. Only data already present in the database of Dr
MEYER have been collected and analysed in this study. Follow-up and
Treatments and collection of adverse events and reactions were among the criteria evaluated
treatment allocation in the management of patients undergoing anterior cruciate ligament
schedule reconstruction.
Data collection: October - December 2022
Data analysis: December 2022 to January 2023
Concomitant No concomitant medication or treatment were administrated or were deemed
medication / as potentially having effect on investigation results.
treatments
Follow-up duration Minimum of 1-year of follow-up

Quantitative variables have been summarised with position indicators (mean

and median), dispersion indicators (corrected standard deviation, 1st and 3rd
quartile, minimum and maximum), a confidence interval (if relevant), the
number and percentage of missing data.
Qualitative variables were described with the number and percentage of each
modality, a confidence interval associated with each percentage (if relevant),
the number and percentage of missing data.
The number of patients was estimated and also presented in each result
Statistical analysis table.
Confidence intervals are two-sided and have been given with a 5% alpha risk.
Demographic and clinical data of the included population and surgery as well
as endpoints and safety data were presented using standard descriptive
statistics.
Statistical methods and analyses may evolve as needed: subgroup analyses

(e.g. groups with different surgical techniques) may be performed for specific
publications or regulatory requirements.
3.3 Ethics considerations
The data collected in this study was taken from the FAST study database. It’s a single-centre prospective
study which included all the patients of five senior surgeons, operated for cruciate knee ligament rupture
in a private clinic of Paris (Clinique du Sport Paris). An Ethical committee IDF VI (Pitié-Salpêtrière)
examined́ the FAST study on 07 February 2013 and confirmed́ that it was an "observational study not
modifying the usual management of the patient". This study complies with the compliance commitment of
the CNIL MR003 procedure. This FAST cohort was registered on ClinicalTrials.gov (NCT02511158).
3.4 Administrative structure of clinical investigation
Sponsor DEDIENNE Santé

Address: Le Mas des Cavaliers, 217 rue Nungesser, 34130 Mauguio, France
Telephone: +33 (0)4 66 28 06 85
Coordinating / Dr. MEYER Alain

Principal Title: Orthopaedic surgeon
Investigator N°RPPS: 10100108801
Address: Institut de chirurgie orthopédique de Paris (CDS – Chirurgie du Sport)
Clinique du Sport, 36 Boulevard Saint-Michel - 75005 Paris
Phone: 01 40 79 40 32
Mail: alainmeyerortho@gmail.com

4 Results
4.1 Initiation date
The investigation began after the first patient inclusion on October 2022.
4.2 Completion date
The investigation was completed on December 2022
4.3 Disposition of subjects
220 patients were followed up for 1-year post-surgery and 134 patients were followed-up for 3 years post-
surgery.
Only 97 patients responded to the clinical questionnaires.
4.4 CIP compliance
Not applicable
4.5 Demographic and preoperative data
4.5.1 Demographic data at first surgery
Table 3 : Preoperative demographic data

N= 220
AGE 30.6 (8.8)
GENDER
Men 138 (63%)
Women 82 (37%)
BMI 24.5 (4.3)
TABAC
Smoker 56 (26%)
Non-smoker 164 (74%)
LATERALITY
Right 122 (56%)
Left 98 (44%)
LEVEL OF SPORTS PARTICIPATION
Recreational level (occasional) 31 (14%)
Recreational level (regular) 115 (52%)
Competitive level 62 (28%)
Professional level 12 (6%)
TYPE OF SPORTS
Contact pivota 119 (54%)

Contactless pivotb 63 (29%)

c
Without pivot 34 (15%)
Not answered 4 (2%)
CIRCUMSTANCES OF THE ACCIDENT
Public road 8 (4%)
Accidents at work 10 (4%)
Sports accident 191 (87%)
Domestic Accident 11 (5%)
a football. handball. rugby. basketball. judo.

b tennis. skiing. badminton. volleyball.
c jogging. cycling. swimming.
Comments:
The mean age was 30.6 (±8.8) years, and the study population was composed of 63% men and 37%
women.
The mean body mass index (BMI) was 24.5 (±4.3).
The patients were mostly non-smokers (74%) and most often had a ruptured ACL on the right side (56%).
Only 6% of the participants played sports professionally and 28% of them at a competitive level. Most of
them were injured during a sports accident (87%) and played a pivotal contact sport.
4.5.2 Clinical score

Various clinical questionnaires were completed by the patients. They are listed and defined below:
• The IKDC (Internal Knee Documentation Committee) which allows a subjective evaluation of the
knee with a score ranging from 0 (worst) to 100 (best),
• The KOOS (Knee Injury and Osteoarthritis Outcome Score), which assesses the knee by
including 5 sub-questionnaires: pain, symptoms, quality of life, daily life, and sport. The result of
these 42 questions are reported out of 100, 0 being the worst and 100 the best,
• The Lysholm assesses the functional capacity of the knee in everyday life. It is composed of 8
items but its total is out of 100, 0 being the worst and 100 the best,
• The Tegner is a scale of physical and professional activities: from 0 (professional disability due
to the knee) to 10 (competitive sport such as football or rugby at national or international level),
• The ACL-RSI (Anterior cruciate ligament return to sport after injury) is a scale that assesses the
psychological impact of returning to sport after anterior cruciate ligament surgery. It is composed
of 12 questions divided into 3 items: emotions, confidence in performance and risk estimation. Its
score ranges from 0 (worst) to 100 (best).

Preoperative clinical scores were completed by all participants included in this study and are detailed in
the table below:
Table 4 : Preoperative clinical score

N= 220
IKDC (/100) 58.8 (16.8)
KOOS SYMPTÔMS-STIFFNESS (/100) 71.3 (19.3)
KOOS PAIN (/100) 74.3 (18.1)
KOOS DAILY LIFE (/100) 83.3 (17.9)
KOOS SPORT (/100) 43.5 (27.8)
KOOS QUALITY OF LIFE (/100) 30.1 (22.9)
LYSHOLM (/100) 69.9 (18.5)
TEGNER (/10) 6.9 (2)
ACL-RSI (/100) 41.5 (24.3)
4.5.3 Peroperative data
All per operative data collected are presented in the table below.
Table 5 : Per operative data

N= 220
ACCIDENT-SURGERY DELAY 8.7 (median: 2.9, Q1: 1.8, Q3: 6.2)
AMBULATORY ADMISSION MODE 71%
LOCO-REGIONAL ANAESTHESIA 100%
INTERNAL MENISCUS LESION 71 (32%)
EXTERNAL MENISCUS LESION 24 (11%)
LAXITY OF THE KNEE* 1 (1%)
EFFUSION**
NO 133 (93%)
AVERAGE 1 (1%)
TRACE 8 (6%)
CHONDROPATHY 18 (8%)
TYPE OF LIGAMENTOPLASTY
DIDT 100%
WITH LEMAIRE'S TENODESIS 48 (22%)
*Knee laxity available for 139 patients.

**effusion available for 142 patients.

Comments:
The mean time from accident to surgery was 8.7 months but the median was only 2.9 months. All patients
underwent surgery under loco-regional anaesthesia and 71% of them were managed as ambulatory.
An internal meniscus lesion was found in 32% of cases, while an external meniscus lesion was present
in only 11% of cases. Only 8% of the patients had a chondropathy.
No complications during surgery were noted.
4.5.4 Medical Device – SMS Screw used.
In 61% of cases, a single 10x30 mm screw was used for DIDT ligamentoplasty.
Table 6 : SMS Screw size distribution

Size Ø9/30mm Size Ø10/30 mm Size Ø11/30 mm
N (%) 66 (30%) 134 (61%) 20 (9%)
Observations:
When the DIDT ligamentoplasty was reinforced with a Lemaire tenodesis, a second screw was used. This
was an SMS Ø7x23mm length screw in 48% of cases (n=23).
5 Data analyses
5.1 Clinical performance and Safety
5.1.1 Safety Assessment – Primary objective

On 220 patients, only 1 (0.5%) had a revision surgery during the first year of follow-up. He was re-operated
at 8.9 months after his first surgery, following a re-rupture at 4 months after the first surgery. He was a
35.1-year-old male at the time of his first operation and was a regular without contact pivotal sports player.
Comments:
In conclusion, the 1-year success rate of the SMS bioresorbable interference screw is 99.5%.
5.1.2 Safety Assessment – Secondary objective

134 patients were evaluated with a 3-year follow-up. Only 6 (4.5%) of these patients required revision
surgery.
The first patient at less than 1-year post-surgery is already described in the paragraph above.
The other 5 were re-hospitalized at an average of 15.7 months post-surgery, following a re-rupture that
occurred at an average of 13.7 months follow-up. The description of the patients who were re-hospitalized
following a re-rupture is presented in Table below.

Table 7 : Description of re-operated patients

Re- Age at
Sport Kind of
n hospitalization Cause Context first Gender Smoker
category sport
time surgery
Sports Regular Contactless
1 8,9 months re-rupture 35,1 Yrs M Yes
accident recreation pivot
Sports
2 14,5 months re-rupture 18,4 Yrs W Professional Pivot contact No
accident
Sports Regular
3 13,9 months re-rupture 19,2 Yrs M Pivot contact No
accident recreation
Sports
4 12,8 months re-rupture 19,6 Yrs M Competition Pivot contact No
accident
Sports
5 14,4 months re-rupture 27,8 Yrs M Competition Pivot contact No
accident
Sports
6 22,9 months re-rupture 29,6 Yrs M Competition Pivot contact Yes
accident
Comments:
In conclusion, at 3-year post-surgery, we observed a success rate of the SMS bioresorbable interference
screw of 95.5%.
We observed that most of the re-rupture were on patients having practiced a pivotal contact sport (83%).
Four patients were involved in sport at a professional or competitive level. The distribution of men and
women is as follows: 83,3% (n=5) / 16,7% (n=1). We notice than two of them are smoker.
5.1.3 Performance Assessment - restoration of joint function

Joint restoration was assessed using the IKDC and KOOS scores, completed by 97 patients at 1 year
post-operatively. Results are summarized in the table below.
Table 8 : Results of functional clinical scores at 1-year post-surgery

AT 1-YEAR
PREOPERATIVE DELTA p-value
POST-SURGERY
IKDC subjective (/100) 57 (15.8) 79.6 (15.6) 22.6 <0.0001
KOOS symptoms-stiffness (/100) 70.2 (18.6) 79.8 (17.1) 9.6 <0.0001
KOOS pains (/100) 72.1 (17.3) 87.5 (13.2) 15.4 <0.0001
KOOS daily life (/100) 81.8 (17.5) 94.2 (10.5) 12.4 <0.0001
KOOS sport (/100) 41.1 (26.6) 75.1 (21.4) 34.0 <0.0001
KOOS quality of life (/100) 26.4 (19.9) 64.6 (22) 38.2 <0.0001

Comments:
The results of these scores increased significantly at 1 year postoperatively compared to the preoperative
results. Joint function was significantly improved.
According to our claims, the IKDC mean score must be ≥ 80 points at 1-year post-surgery. We observed
an IKDC mean score of 79.6 at 1-year. This result validates our performance claims.
According to our claims, the KOOS mean score must be ≥ 80 points at 1-year post-surgery. We observed
an KOOS mean score of 80,24 points. These results validate our performance claims.
5.1.4 Performance Assessment - resumption of daily physical activity.

Resumption of daily activity was assessed using the Lysholm and Tegner scores, completed by 97
patients at 1 year post-operatively. Results are available in the table below.
Table 9 : Lysholm and Tegner score at 1-year post-surgery.

At 1-year post-
Preoperative DELTA p-value
surgery
Lysholm (/100) 68.4 (18.2) 86.3 (12.9) 17,9 <0.0001
At 1-year post-
Before injury DELTA p-value
surgery
TEGNER (/10) 7.0 (1.9) 5.7 (2) -1,3 <0.0001
Comments:
The mean Lysholm score increased significantly at 1-year post-surgery and the mean post-operative
score is 86.3. According to our claims, the Lysholm score must be higher than 65 at 1-year post-surgery.
We are in line’s with our claims.
Concerning the TEGNER score and according to our claims, it must be superior or egal to 4,9 points at
1-year post-surgery. We notice a TEGNER score of 5,7 points at 1-year post-surgery, which is well above
to 4.9 points and in line with our claim.
In the state of the art, we notice that the preoperative score is generally superior or egal to 2,5 points. In
this study, we observed a preoperative score of 7.0 which is abnormally high. We can explain this result
by the fact that the preoperative questionnaire was completed after the surgery, and not before the
incident occurs, according to the patients' feelings and observations. The TEGNER preoperative score is
then biased.
5.1.5 Performance Assessment – Return to physical activity.

The mean ACL-RSI score was calculated at 1-year post-surgery to assess the impact of psychological
factors on return to sport at the same level among the 97 patients who completed the 1-year
questionnaire. See results in the table below.
Table 10 : ACL-RSI score at 1-year post-surgery

1-year post-
Preoperative DELTA p-value
surgery
ACL RSI SCORE (/100) 40.6 (23.4) 64.4 (21.7) 23.8 <0.0001

Table 11 : Return to sport at 1-year post-surgery for all patients.

In all patients (n=97)
RUN RESTART
YES 74%
NO 26%
TIME TO RETURN RUNNING IN MONTHS 10 (2.9)
RETURN TO THE SAME SPORT
YES 48%
NO 52%
TIME TO RETURN TO SPORT IN MONTHS 9.5 (2.9)
Is the return to sport for professionals and competitors faster? Of the 97 patients who responded to the
questionnaires, 35 patients were professional sportsmen and women or competitors.
Table 12 : Return to sport at 1-year post-surgery for professionals & competitors.

Non-professionals /
Professionals /
competitors p-value
competitors (n=35)
(n=62)
RUN RESTART 0.15
YES 83% 69%
NO 17 % 31%
TIME TO RETURN RUNNING IN
9.6 (2.5) 10.3 (3.3) 0.38
MONTHS
RETURN TO THE SAME SPORT 0.045
YES 63% 39%
NO 37% 61%
TIME TO RETURN SPORT IN
8.9 (2.6) 10.1 (3.1) 0.20
MONTHS
Comments:
On average, the ACL-RSI score increased significantly at 1-year post-surgery compared to the mean
score pre-surgery, 64.4 (21.7) versus 40.6 (23.4), p<0.0001.
In addition, 74% of patients returned to running within a mean of 10 (2.9) months and 48% of them
returned to the same pre-injury sport within 9.5 (2.9) months.
In the table 12, we observed that 83% of professionals and competitors patients returned to running within
a mean of 9.6 (2.5) months in comparison with non-professionals /competitors’ patients, who 69%
returned to running within a mean of 10.3. This observation is not significative.
However we notice that 63% of professionals / competitors patients returned to the same sport within 8.9
(2.6) months in comparison of non-professional / competitors patients who are 39% to returned to the
same sport within 10.1 (3.1) months (p-value <0.05). The rate of return to sport is significantly higher for
competitors/professionals than for other non-professionals/competitors.

5.1.6 Adverse Events Assessment
We notice only three adverse events that required revision surgery. See the table below.
Re-
Age at first Sport Kind of
n hospitaliz Cause Context Gender
surgery category sport
ation time
Sports
1 9,9 months Meniscectomy 19 M Competition Contact pivot
accident
11,3 Cyclope Sports Regular Contactless
2 39,6 F
months syndrom accident hobbies pivot
33,2 Sports
3 Meniscectomy 19,7 F Competition Contact pivot
months accident
Comments:
We notice two patients re-hospitalized for meniscectomy at respectively 9,9 months and 33,2 months
post-surgery.
One patient has developed a cyclop syndrome, which is characterized by the formation of a fibrous scar
within the joint. This small scar ball (or nodule) develops just in front of the new anterior cruciate ligament
and limits knee extension. This syndrome represents 0.45% (n=1) of the study population. This
percentage in line with our claims.
2 cases of meniscectomy are observed. These events are often described in the literature. There are no
unexpected adverse events.
We observed an adverse events rate of 1,4%.
5.2 Device malfunction
No device malfunctions nor corrective actions were observed or taken during the clinical investigation.
5.3 Subgroup analyses
No subgroup analysis.
5.4 Missing data handling
No missing data
5.5 Additional analyses
No additional analysis.
5.6 Patient’s deaths or lost to follow-up.

Not applicable

6 Discussion and conclusion

This retrospective study collected and analysed data from 220 patients for whom a SMS screw was
implanted with a follow-up time between 1 and 3 years.
This patient cohort is composed of 82 women and 138 men with mean ages of 30,6 years. The body mass
index for both men and women indicate normal weight (24,5), according to the WHO classification. In
74% of cases, the patients were non-smokers.
We can observe that the most patients have a regular recreational sport practice (52%) and 54% practised
a contact pivot sport. 87% of the patients had their ACL ruptured during their sporting activity 56% of ACL
ruptured were in the right side.
We notice that the mean delay between the accident and the surgery was 8,7 months (± 2,9 months). All
patients were managed under loco-regional anaesthesia and 71% of them in ambulatory. 93% of patients
had an effusion.
100% of patients had ACL surgery using the surgical technique of anterior cruciate ligament or ACL
ligamentoplasty using a graft made from the tendons of the medial rectus and semitendinosus muscles.
61% of surgeries had been made with one SMS screw with a size of 10x30 mm.
From the point of view of safety evaluation at 1-year post-surgery (the main objective of the study), the
surgery success rate is of 99,5% which validates our main objective. The rate at 3-years of follow-up is of
95,5%. We notice 6 graft ruptures in three years post-surgery that represent 4,5% of surgeries. Four
patients were involved in a sport at a professional or competitive level. 83% of the patients who had a re-
rupture were men.
Results of clinical questionnaire score show that the joint function was significantly improved at 1 year
post-operatively for the 97 patients who completed the questionnaires. We notice, for the same
population, a return to a functional capacity of the knee in daily life significantly improved.
74% of patients had return in running within a delay of 10 months (±2,9). The delay to return to sport is of
9.5 months. On the basis of 35 professional athletes, the return rate to the run is 83%. The delay to return
to sport is of 8,9 months.
In term of adverse events, only 3 events are observed, representing 1.4% of the study population. The
graft revision rate is very low and is 2,7% at 3 years post-surgery. One cyclop syndrom is noticed, that
represents 0.45%. No effusion or infection are observed.
In conclusion, the performance and the safety of the SMS screw device has been demonstrated in this
retrospective study.


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Rapport d’Investigation Clinique

Version 1.0 – PMCF_SMS_01

CLINICAL INVESTIGATION REPORT

« RETROSPECTIVE STUDY EVALUATING THE PERFORMANCE AND SAFETY

Sponsor : DEDIENNE Santé

This report was written by: Matthieu MERLOT

Confidentiel Page 1 sur 23

Sponsor’s representative Signature

Coordinating/Principal investigator Signature

Dr MEYER Alain, Orthopaedic Surgeon Date:

Confidential Page 2 sur 23

Tables and Figures

Confidential Page 3 sur 23

3 Investigational device and methods .................................................................................... 8

3.2 Clinical investigation plan 11

4.1 Initiation date 14

5 Data analyses ............................................................................................................................... 17

5.1 Clinical performance and Safety 17

5.2 Device malfunction 21

Confidential Page 4 sur 23

Abbreviations and Definitions

ACL Anterior Cruciate Ligament

BMI Body Mass Index

CRF Case Report Form

IKDC International Knee Documentation Committee

KOOS Knee Injury and Osteoarthritis Outcome Score

PMCF Post Market Clinical Follow-up

QOL Quality of Life

SAE Serious Adverse Event

SMS Screw SMS Bioresorbable Interference Screw

Confidential Page 5 sur 23

The SMS Bioresorbable Interference Screw is a fully threaded, cannulated and

Results See paragraph 4 & 5

Initiation date October 2022

Completion date February 2023

Confidential Page 6 sur 23

Figure 1 : Rupture of the anterior cruciate ligament

Confidential Page 7 sur 23

1. ATIH: Agence technique de l’information sur l’hospitalisation. https://www.atih.sante.fr/.

members. Eur J Orthop Surg Traumatol 26, 509–516 (2016).

3. Tamalet, B. & Rochcongar, P. Épidémiologie et prévention de la rupture du ligament croisé antérieur

du genou. Revue du Rhumatisme Monographies 83, 103–107 (2016).

3 Investigational device and methods

3.1 Investigational device description

3.1.1 Manufacturer identification

3.1.2 CE-marking history / Device Status

3.1.3 Device description

Confidential Page 8 sur 23

Figure 2 : SMS Screw implantable devices

Table 1 : SMS Screw range devices

Common name Designation Reference

3.1.4 Intended use

3.1.5 Description of clinical performance

Confidential Page 9 sur 23

*Note1: Improvement is achieved when one of the following conditions is met:

3.1.6 Changes to the investigational device

Confidential Page 10 sur 23

3.2 Clinical investigation plan

N° Primary objective Primary endpoint

N° Secondary objectives Secondary endpoints

Single-centre, retrospective, non-interventional study not directly involving

Confidential Page 11 sur 23

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