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

Teknimed

Status: Enrolling

Conditions: Sport Surgery

Treatments: Device: Orthopaedic surgeries (knee); Device: Orthopaedic surgeries (ankle); Device: Orthopaedic surgeries; Device: Orthopaedic surgeries (foot); Device: Orthopaedic surgeries (shoulder)

Study type: Observational

Funder types: Industry

Identifiers

NCT06532929

SM01-TK-SPORTS

Details and patient eligibility

About

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.

Full 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

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

390 participants in 9 patient groups

EUROSCREW NG PLA knee (ACL) surgery

Description:

Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA

Treatment:

Device: Orthopaedic surgeries (knee)

EUROSCREW NG PLA knee (PCL) surgery

Description:

Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA

Treatment:

Device: Orthopaedic surgeries (knee)

EUROSCREW NG PLA ankle surgery

Description:

Patients included for ankle surgery with EUROSCREW NG PLA

Treatment:

Device: Orthopaedic surgeries (ankle)

EUROSCREW NG PLA/TCP knee (ACL) surgery

Description:

Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP

Treatment:

Device: Orthopaedic surgeries (knee)

EUROSCREW NG PLA/TCP knee (PCL) surgery

Description:

Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP

Treatment:

Device: Orthopaedic surgeries (knee)

ISOFIX knee (ACL) surgery

Description:

Patients included for anterior crucial ligament of knee surgery with ISOFIX

Treatment:

Device: Orthopaedic surgeries (knee)

A'LINK'S shoulder surgery

Description:

Patients included for shoulder surgery with A'LINK'S

Treatment:

Device: Orthopaedic surgeries (shoulder)

SUTUR'LINK surgery

Description:

Patients included for surgery with SUTUR'LINK

Treatment:

Device: Orthopaedic surgeries

PINS foot surgery

Description:

Patients included for foot surgery with PINS

Treatment:

Device: Orthopaedic surgeries (foot)