Sport Surgery Products Outcomes - A Post-market Follow-up

March 24, 2025 updated by: Teknimed

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Ardèche
      • Aubenas, Ardèche, France, 07200
        • Not yet recruiting
        • Milaire
        • Principal Investigator:
          • Michel MILAIRE, MD
        • Contact:
      • Guilherand-Granges, Ardèche, France, 07500
        • Recruiting
        • Centre Claude Bernard
        • Contact:
        • Principal Investigator:
          • Richard PHILIPPE, MD
      • Guilherand-Granges, Ardèche, France, 07500
        • Recruiting
        • Centre Mistral -Clinique Pasteur
        • Contact:
        • Principal Investigator:
          • Grégory NAVEZ, MD
    • Corrèze
      • Brive-la-Gaillarde, Corrèze, France, 19100
        • Recruiting
        • Orthopole des 3 provinces
        • Contact:
        • Principal Investigator:
          • Alain HARISBOURE, MD
    • Dordogne
      • Bergerac, Dordogne, France, 24100
        • Recruiting
        • Clinique Pasteur
        • Contact:
        • Principal Investigator:
          • Carlos FERRER, MD
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31100
        • Recruiting
        • Médipôle Toulouse
        • Contact:
        • Principal Investigator:
          • Christophe JAVOIS, MD
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87000
        • Completed
        • Clinique Chenieux
    • Hérault
      • Boujan-sur-Libron, Hérault, France, 34760
        • Recruiting
        • Clinique St Privat
        • Contact:
        • Principal Investigator:
          • Guillaume MIROUSE, MD
      • Lunel, Hérault, France, 34400
        • Active, not recruiting
        • Clinique Via Domitia
    • Lot-et-Garonne
      • Agen, Lot-et-Garonne, France, 47000
        • Recruiting
        • Clinique Esquirol Saint-Hilaire
        • Contact:
        • Principal Investigator:
          • Damien LAQUES, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EUROSCREW NG PLA knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA
Device: Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
EUROSCREW NG PLA knee (PCL) surgery
Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA
Device: Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
EUROSCREW NG PLA ankle surgery
Patients included for ankle surgery with EUROSCREW NG PLA
Device: Orthopaedic surgeries (ankle)
ankle lateral ligament reconstruction in ligamentoplasty procedures
EUROSCREW NG PLA/TCP knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP
Device: Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
EUROSCREW NG PLA/TCP knee (PCL) surgery
Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP
Device: Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
ISOFIX knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with ISOFIX
Device: Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
A'LINK'S shoulder surgery
Patients included for shoulder surgery with A'LINK'S
Device: Orthopaedic surgeries (shoulder)
rotator cuff repair
SUTUR'LINK surgery
Patients included for surgery with SUTUR'LINK
Device: Orthopaedic surgeries
rotator cuff repair or closure of capsule after arthroplasty surgery
PINS foot surgery
Patients included for foot surgery with PINS
Device: Orthopaedic surgeries (foot)
stabilization of metatarsal and phalangeal osteotomies during treatment of hallux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years (until the lifetime of the device)
Adverse event
Time Frame: 5 years
Adverse event related to sports surgery products
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 4 years
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
4 years
Antalgic consumption
Time Frame: 4 years
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
4 years
Patients' satisfaction
Time Frame: 4 years
Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
4 years
Quality of patient life
Time Frame: 4 years
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)
4 years
Radiological outcomes
Time Frame: 4 years
Evaluation of implants integrity/ resorption Bioresorbable screws, pins and anchors will be classified as "degraded", "partially intact" or "intact", as observed on imaging exam.
4 years
Devices and instrumentations usability
Time Frame: Once, during surgery

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).
Once, during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teknimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Estimated)

November 1, 2036

Study Completion (Estimated)

November 1, 2036

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SM01-TK-SPORTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sport Surgery

Clinical Trials on Orthopaedic surgeries (knee)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe