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.
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
Study Type
OBSERVATIONAL
Enrollment
390
ankle lateral ligament reconstruction in ligamentoplasty procedures
rotator cuff repair
knee cruciate ligaments reconstruction in ligamentoplasty procedures
Milaire
Aubenas, Ardèche, France
NOT_YET_RECRUITINGCentre Claude Bernard
Guilherand-Granges, Ardèche, France
RECRUITINGCentre Mistral -Clinique Pasteur
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
Time frame: 4 years (until the lifetime of the device)
Adverse event
Adverse event related to sports surgery products
Time frame: 5 years
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
Time frame: 4 years
Antalgic consumption
Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Time frame: 4 years
Patients' satisfaction
Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
Time frame: 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)
Time frame: 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.
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rotator cuff repair or closure of capsule after arthroplasty surgery
stabilization of metatarsal and phalangeal osteotomies during treatment of hallux
Guilherand-Granges, Ardèche, France
Orthopole des 3 provinces
Brive-la-Gaillarde, Corrèze, France
RECRUITINGClinique Pasteur
Bergerac, Dordogne, France
RECRUITINGMédipôle Toulouse
Toulouse, Haute-Garonne, France
RECRUITINGClinique Chénieux
Limoges, Haute-Vienne, France
COMPLETEDClinique St Privat
Boujan-sur-Libron, Hérault, France
RECRUITINGClinique Via Domitia
Lunel, Hérault, France
ACTIVE_NOT_RECRUITINGClinique Esquirol Saint-Hilaire
Agen, Lot-et-Garonne, France
RECRUITINGTime frame: 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).
Time frame: Once, during surgery