Sport SurgeryNCT06532929
Sport Surgery Products Outcomes - A Post-market Follow-up
An observational study of Sport Surgery, run by Teknimed at 10 sites in France.
Trial summary
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sport Surgery
- What is being tested?
- Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder) and Orthopaedic surgeries (knee)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 390 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Nov 2019to Nov 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People suffering from tears or ruptures of ligaments or tendons and in need of an orthopaedic surgery, according to the specific intended uses related to each device.
Who may be able to join
- Be 18 years or older.
- Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)
- For prospective inclusion:
- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.
- For retrospective inclusion:
- Have undergone a surgery with a TEKNIMED sports surgery product between the 1st January 2016 and the date of the site initiation visit.
- Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).
Who cannot join
- Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy
- Anyone of the contraindications mentioned in the respective IFU of each device under study
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 8 recruiting
- Recruiting
Clinique Esquirol Saint-Hilaire
Agen, Lot-et-Garonne, 47000
Damien LAQUES, MD, damien.laques@wanadoo.fr
Damien LAQUES, MD
- Not yet recruiting
Milaire
Aubenas, Ardèche, 07200
Michel MILAIRE, MD, 04 75 35 70 00, michel.milaire@yahoo.com
Michel MILAIRE, MD
- Recruiting
Clinique Pasteur
Bergerac, Dordogne, 24100
Carlos FERRER, MD, carlos.ferrer@hotmail.fr
Carlos FERRER, MD
- Recruiting
Clinique St Privat
Boujan-sur-Libron, Hérault, 34760
Guillaume MIROUSE, MD, gmirouse@gmail.com
Guillaume MIROUSE, MD
- Recruiting
Orthopole des 3 provinces
Brive-la-Gaillarde, Corrèze, 19100
Alain HARISBOURE, MD, a.harisboure@orthocedres19.fr
Alain HARISBOURE, MD
- Recruiting
Centre Claude Bernard
Guilherand-Granges, Ardèche, 07500
Richard PHILIPPE, MD, richard.philippe@ccb07.org
Richard PHILIPPE, MD
- Recruiting
Centre Mistral -Clinique Pasteur
Guilherand-Granges, Ardèche, 07500
Grégory NAVEZ, MD, gregory.navez@gmail.com
Grégory NAVEZ, MD
- Completed
Clinique Chénieux
Limoges, Haute-Vienne, 87000
- Active, not recruiting
Clinique Via Domitia
Lunel, Hérault, 34400
- Recruiting
Médipôle Toulouse
Toulouse, Haute-Garonne, 31100
Christophe JAVOIS, MD, christophe.javois@yahoo.fr
Christophe JAVOIS, MD
About this study
Official title: Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products.
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.
Read the detailed description
It is admitted that:
- Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction,
- Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes,
- Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures,
- Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis.
Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined.
This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use.
Studied products include - but are not restricted to - the following TEKNIMED products:
- EUROSCREW® NG
- ISOFIX®
- SUTUR'LINK®
- A'LINK'S®
- BIORESORBABLE PINS
And following associated TEKNIMED instrumentation:
- ACL Instrumentation
- A'LINK'S® Instrumentation
- STAINLESS STEEL PINS
- Conditions
- Sport Surgery
- Being tested
- Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee), Orthopaedic surgeries, Orthopaedic surgeries (foot)
- Keywords
- knee, shoulder, sport, surgery, suture, ligamentoplasty, anchors, screw, resorbable, pins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic surgeries (ankle)Device
ankle lateral ligament reconstruction in ligamentoplasty procedures
Orthopaedic surgeries (shoulder)Device
rotator cuff repair
Orthopaedic surgeries (knee)Device
knee cruciate ligaments reconstruction in ligamentoplasty procedures
Orthopaedic surgeriesDevice
rotator cuff repair or closure of capsule after arthroplasty surgery
Orthopaedic surgeries (foot)Device
stabilization of metatarsal and phalangeal osteotomies during treatment of hallux
| Study group | Role | What they receive |
|---|---|---|
| EUROSCREW NG PLA knee (ACL) surgery | Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA Receives: Device: Orthopaedic surgeries (knee) | |
| EUROSCREW NG PLA knee (PCL) surgery | Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA Receives: Device: Orthopaedic surgeries (knee) | |
| EUROSCREW NG PLA ankle surgery | Patients included for ankle surgery with EUROSCREW NG PLA Receives: Device: Orthopaedic surgeries (ankle) | |
| EUROSCREW NG PLA/TCP knee (ACL) surgery | Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP Receives: Device: Orthopaedic surgeries (knee) | |
| EUROSCREW NG PLA/TCP knee (PCL) surgery | Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP Receives: Device: Orthopaedic surgeries (knee) | |
| ISOFIX knee (ACL) surgery | Patients included for anterior crucial ligament of knee surgery with ISOFIX Receives: Device: Orthopaedic surgeries (knee) | |
| A'LINK'S shoulder surgery | Patients included for shoulder surgery with A'LINK'S Receives: Device: Orthopaedic surgeries (shoulder) | |
| SUTUR'LINK surgery | Patients included for surgery with SUTUR'LINK Receives: Device: Orthopaedic surgeries | |
| PINS foot surgery | Patients included for foot surgery with PINS Receives: Device: Orthopaedic surgeries (foot) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of join function
Function will be evaluated from standardized and validated clinical questionnaires, with few questions relative to domains such as pain, mobility, range of motion... which are specific for one joint
Measured: 4 years (until the lifetime of the device)
Adverse event
Adverse event related to sports surgery products
Measured: 5 years
Secondary outcomes (6)
Pain level
Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits
Measured: 4 years
Antalgic consumption
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Measured: 4 years
Patients' satisfaction
Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
Measured: 4 years
Quality of patient life
Quality of patient life assessed using Well-Being questionnaire (6 questions with a scale of 0 to 10, with 0 being not at all and 10 being the better response at the Baseline and at the Follow-up visits)
Measured: 4 years
Radiological outcomes
Evaluation of implants integrity/ resorption Bioresorbable screws, pins and anchors will be classified as "degraded", "partially intact" or "intact", as observed on imaging exam.
Measured: 4 years
Devices and instrumentations usability
Instrumentations usability assessed by physician evaluation of the sucessive phases of surgery.
The physician is asked to evaluate the successive phases of the surgery to assess the global device usability. For each technical phase, he has to choose between 3 propositions: Easy, Difficult or Impossible. At the end of the surgical procedure, the surgeon is asked to assess the resulting joint stability (stable or unstable).
Measured: Once, during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Nov 2019
- Primary completionNov 2036 (estimated)
- Study completionNov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teknimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532929
- Sponsor's protocol ID
- SM01-TK-SPORTS
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
- ClinicalTrials.gov ID
- NCT06532929
- Acronym / sponsor ID
- SM01-TK-SPORTS
- Conditions
- Sport Surgery
- Keywords
- knee, shoulder, sport, surgery, suture, ligamentoplasty, anchors, screw
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- TeknimedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Nov 2036 (estimated)
- Study completion
- Nov 2036 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products.
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.
Detailed description
It is admitted that:
- Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction,
- Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes,
- Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures,
- Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis.
Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined.
This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use.
Studied products include - but are not restricted to - the following TEKNIMED products:
- EUROSCREW® NG
- ISOFIX®
- SUTUR'LINK®
- A'LINK'S®
- BIORESORBABLE PINS
And following associated TEKNIMED instrumentation:
- ACL Instrumentation
- A'LINK'S® Instrumentation
- STAINLESS STEEL PINS
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| EUROSCREW NG PLA knee (ACL) surgery | – | Device: Orthopaedic surgeries (knee)Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA |
| EUROSCREW NG PLA knee (PCL) surgery | – | Device: Orthopaedic surgeries (knee)Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA |
| EUROSCREW NG PLA ankle surgery | – | Device: Orthopaedic surgeries (ankle)Patients included for ankle surgery with EUROSCREW NG PLA |
| EUROSCREW NG PLA/TCP knee (ACL) surgery | – | Device: Orthopaedic surgeries (knee)Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP |
| EUROSCREW NG PLA/TCP knee (PCL) surgery | – | Device: Orthopaedic surgeries (knee)Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP |
| ISOFIX knee (ACL) surgery | – | Device: Orthopaedic surgeries (knee)Patients included for anterior crucial ligament of knee surgery with ISOFIX |
| A'LINK'S shoulder surgery | – | Device: Orthopaedic surgeries (shoulder)Patients included for shoulder surgery with A'LINK'S |
| SUTUR'LINK surgery | – | Device: Orthopaedic surgeriesPatients included for surgery with SUTUR'LINK |
| PINS foot surgery | – | Device: Orthopaedic surgeries (foot)Patients included for foot surgery with PINS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People suffering from tears or ruptures of ligaments or tendons and in need of an orthopaedic surgery, according to the specific intended uses related to each device.
Key inclusion criteria (7 listed)
- Be 18 years or older.
- Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)
- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.
- Have undergone a surgery with a TEKNIMED sports surgery product between the 1st January 2016 and the date of the site initiation visit.
- Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).
Key exclusion criteria (2 listed)
- Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy
- Anyone of the contraindications mentioned in the respective IFU of each device under study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopaedic surgeries (ankle)ankle lateral ligament reconstruction in ligamentoplasty procedures | Device | EUROSCREW NG PLA ankle surgery |
| Orthopaedic surgeries (shoulder)rotator cuff repair | Device | A'LINK'S shoulder surgery |
| Orthopaedic surgeries (knee)knee cruciate ligaments reconstruction in ligamentoplasty procedures | Device | EUROSCREW NG PLA knee (ACL) surgery, EUROSCREW NG PLA knee (PCL) surgery, EUROSCREW NG PLA/TCP knee (ACL) surgery, EUROSCREW NG PLA/TCP knee (PCL) surgery, ISOFIX knee (ACL) surgery |
| Orthopaedic surgeriesrotator cuff repair or closure of capsule after arthroplasty surgery | Device | SUTUR'LINK surgery |
| Orthopaedic surgeries (foot)stabilization of metatarsal and phalangeal osteotomies during treatment of hallux | Device | PINS foot surgery |
Primary outcome
Evaluation of join function
Time frame: 4 years (until the lifetime of the device)
Function will be evaluated from standardized and validated clinical questionnaires, with few questions relative to domains such as pain, mobility, range of motion... which are specific for one joint
Adverse event
Time frame: 5 years
Adverse event related to sports surgery products
6 secondary outcomes
Pain level
Time frame: 4 years
Antalgic consumption
Time frame: 4 years
Patients' satisfaction
Time frame: 4 years
Quality of patient life
Time frame: 4 years
Radiological outcomes
Time frame: 4 years
Devices and instrumentations usability
Time frame: Once, during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sport Surgery, run by Teknimed at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solange VAN DE MOORTELE, PhD (+33 5 34 25 26 79, s.vandemoortele@teknimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of join function (time frame: 4 years (until the lifetime of the device)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.