RecruitingNCT06532929

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

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

Sponsor

Teknimed

Enrollment

390 participants

Start Date

Nov 1, 2019

Study Type

OBSERVATIONAL

Conditions

Sport Surgery

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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).

Exclusion Criteria2

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

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Interventions

DEVICEOrthopaedic surgeries (ankle)

ankle lateral ligament reconstruction in ligamentoplasty procedures

DEVICEOrthopaedic surgeries (shoulder)

rotator cuff repair

DEVICEOrthopaedic surgeries (knee)

knee cruciate ligaments reconstruction in ligamentoplasty procedures

DEVICEOrthopaedic surgeries

rotator cuff repair or closure of capsule after arthroplasty surgery

DEVICEOrthopaedic surgeries (foot)

stabilization of metatarsal and phalangeal osteotomies during treatment of hallux

Locations(10)

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

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NCT06532929