Sport Surgery Products Outcomes - A Post-market Follow-up
NCT Number: NCT06532929
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sport Surgery
Interventions: DEVICE: Orthopaedic surgeries (ankle)|DEVICE: Orthopaedic surgeries (shoulder)|DEVICE: Orthopaedic surgeries (knee)|DEVICE: Orthopaedic surgeries|DEVICE: Orthopaedic surgeries (foot)
Sponsor: Teknimed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 560
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-11-01
Completion Date: 2026-11
Locations: Centre Claude Bernard, Guilherand-Granges, Ardèche, 07500, France|Centre Mistral -Clinique Pasteur, Guilherand-Granges, Ardèche, 07500, France|Orthopole des 3 provinces, Brive-la-Gaillarde, Corrèze, 19100, France|Clinique Pasteur, Bergerac, Dordogne, 24100, France|Médipôle Toulouse, Toulouse, Haute-Garonne, 31100, France|Clinique Chénieux, Limoges, Haute-Vienne, 87000, France|Clinique St Privat, Boujan-sur-Libron, Hérault, 34760, France|Clinique Via Domitia, Lunel, Hérault, 34400, France|Clinique Esquirol Saint-Hilaire, Agen, Lot-et-Garonne, 47000, France

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.

Primary Outcome Measures: Evaluation of join function, Function will be evaluated from standardized and validated clinical questionnaires, with few questions relative to domains such as pain, mobility, range of motion... which are specific for one joint, 4 years (until the lifetime of the device)|Adverse event, Adverse event related to sports surgery products, 5 years
Secondary Outcome Measures: Pain level, Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits, 4 years|Antalgic consumption, Antalgic consumption and the drug type at the Baseline and at the Follow-up visits, 4 years|Patients' satisfaction, Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits, 4 years|Quality of patient life, Quality of patient life assessed using Well-Being questionnaire (6 questions with a scale of 0 to 10, with 0 being not at all and 10 being the better response at the Baseline and at the Follow-up visits), 4 years|Radiological outcomes, Evaluation of implants integrity/ resorption Bioresorbable screws, pins and anchors will be classified as "degraded", "partially intact" or "intact", as observed on imaging exam., 4 years|Devices and instrumentations usability, Instrumentations usability assessed by physician evaluation of the sucessive phases of surgery.

The physician is asked to evaluate the successive phases of the surgery to assess the global device usability. For each technical phase, he has to choose between 3 propositions: Easy, Difficult or Impossible. At the end of the surgical procedure, the surgeon is asked to assess the resulting joint stability (stable or unstable)., Once, during surgery