Sport Surgery Products Outcomes - A Post-market Follow-up
NCT ID: NCT06532929
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
390 participants
OBSERVATIONAL
2019-11-01
2036-11-30
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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COHORT
OTHER
Study Groups
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EUROSCREW NG PLA knee (ACL) surgery
Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA
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
Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
EUROSCREW NG PLA ankle surgery
Patients included for ankle surgery with EUROSCREW NG PLA
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
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
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
Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
A'LINK'S shoulder surgery
Patients included for shoulder surgery with A'LINK'S
Orthopaedic surgeries (shoulder)
rotator cuff repair
SUTUR'LINK surgery
Patients included for surgery with SUTUR'LINK
Orthopaedic surgeries
rotator cuff repair or closure of capsule after arthroplasty surgery
PINS foot surgery
Patients included for foot surgery with PINS
Orthopaedic surgeries (foot)
stabilization of metatarsal and phalangeal osteotomies during treatment of hallux
Interventions
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Orthopaedic surgeries (ankle)
ankle lateral ligament reconstruction in ligamentoplasty procedures
Orthopaedic surgeries (shoulder)
rotator cuff repair
Orthopaedic surgeries (knee)
knee cruciate ligaments reconstruction in ligamentoplasty procedures
Orthopaedic surgeries
rotator cuff repair or closure of capsule after arthroplasty surgery
Orthopaedic surgeries (foot)
stabilization of metatarsal and phalangeal osteotomies during treatment of hallux
Eligibility Criteria
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Inclusion Criteria
* 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
* Anyone of the contraindications mentioned in the respective IFU of each device under study
18 Years
ALL
No
Sponsors
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Teknimed
INDUSTRY
Responsible Party
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Locations
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Milaire
Aubenas, Ardèche, France
Centre Claude Bernard
Guilherand-Granges, Ardèche, France
Centre Mistral -Clinique Pasteur
Guilherand-Granges, Ardèche, France
Orthopole des 3 provinces
Brive-la-Gaillarde, Corrèze, France
Clinique Pasteur
Bergerac, Dordogne, France
Médipôle Toulouse
Toulouse, Haute-Garonne, France
Clinique Chénieux
Limoges, Haute-Vienne, France
Clinique St Privat
Boujan-sur-Libron, Hérault, France
Clinique Via Domitia
Lunel, Hérault, France
Clinique Esquirol Saint-Hilaire
Agen, Lot-et-Garonne, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SM01-TK-SPORTS
Identifier Type: -
Identifier Source: org_study_id
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