Sport Surgery Products Outcomes - A Post-market Follow-up
Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
1 other identifier
observational
390
1 country
10
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2036
March 27, 2025
March 1, 2025
17 years
July 25, 2024
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
4 years (until the lifetime of the device)
Adverse event
Adverse event related to sports surgery products
5 years
Secondary Outcomes (6)
Pain level
4 years
Antalgic consumption
4 years
Patients' satisfaction
4 years
Quality of patient life
4 years
Radiological outcomes
4 years
- +1 more secondary outcomes
Study Arms (9)
EUROSCREW NG PLA knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA
EUROSCREW NG PLA knee (PCL) surgery
Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA
EUROSCREW NG PLA ankle surgery
Patients included for ankle surgery with EUROSCREW NG PLA
EUROSCREW NG PLA/TCP knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP
EUROSCREW NG PLA/TCP knee (PCL) surgery
Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP
ISOFIX knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with ISOFIX
A'LINK'S shoulder surgery
Patients included for shoulder surgery with A'LINK'S
SUTUR'LINK surgery
Patients included for surgery with SUTUR'LINK
PINS foot surgery
Patients included for foot surgery with PINS
Interventions
ankle lateral ligament reconstruction in ligamentoplasty procedures
knee cruciate ligaments reconstruction in ligamentoplasty procedures
rotator cuff repair or closure of capsule after arthroplasty surgery
stabilization of metatarsal and phalangeal osteotomies during treatment of hallux
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teknimedlead
Study Sites (10)
Milaire
Aubenas, Ardèche, 07200, France
Centre Claude Bernard
Guilherand-Granges, Ardèche, 07500, France
Centre Mistral -Clinique Pasteur
Guilherand-Granges, Ardèche, 07500, France
Orthopole des 3 provinces
Brive-la-Gaillarde, Corrèze, 19100, France
Clinique Pasteur
Bergerac, Dordogne, 24100, France
Médipôle Toulouse
Toulouse, Haute-Garonne, 31100, France
Clinique Chénieux
Limoges, Haute-Vienne, 87000, France
Clinique St Privat
Boujan-sur-Libron, Hérault, 34760, France
Clinique Via Domitia
Lunel, Hérault, 34400, France
Clinique Esquirol Saint-Hilaire
Agen, Lot-et-Garonne, 47000, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 1, 2024
Study Start
November 1, 2019
Primary Completion (Estimated)
November 1, 2036
Study Completion (Estimated)
November 1, 2036
Last Updated
March 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share