Sport Surgery Products Outcomes - A Post-market Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee), Orthopaedic surgeries.
- Who it may be relevant to
- Registry conditions: Sport Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
Overview
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
Interventions
- 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
Primary outcome measures
- Evaluation of join function [Time frame: 4 years (until the lifetime of the device)]
- Adverse event [Time frame: 5 years]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 10 centers
- Milaire — Aubenas
- Centre Claude Bernard — Guilherand-Granges
- Centre Mistral -Clinique Pasteur — Guilherand-Granges
- Orthopole des 3 provinces — Brive-la-Gaillarde
- Clinique Pasteur — Bergerac
- Médipôle Toulouse — Toulouse
- Clinique Chénieux — Limoges
- Clinique St Privat — Boujan-sur-Libron
- … and 2 more centers
Identifiers
NCT: NCT06532929 · SM01-TK-SPORTS