NCT06532929

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

Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 390 (estimated)
• Sponsor: Teknimed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Orthopaedic surgeries (ankle)	ankle lateral ligament reconstruction in ligamentoplasty procedures
DEVICE	Orthopaedic surgeries (shoulder)	rotator cuff repair
DEVICE	Orthopaedic surgeries (knee)	knee cruciate ligaments reconstruction in ligamentoplasty procedures
DEVICE	Orthopaedic surgeries	rotator cuff repair or closure of capsule after arthroplasty surgery
DEVICE	Orthopaedic surgeries (foot)	stabilization of metatarsal and phalangeal osteotomies during treatment of hallux

Timeline

• Start date: 2019-11-01
• Primary completion: 2036-11-01
• Completion: 2036-11-01
• First posted: 2024-08-01
• Last updated: 2025-03-27

Locations

10 sites across 1 country: France