Sport Surgery Products Outcomes - A Post-market Follow-up
- Conditions
- Sport Surgery
- Interventions
- Device: Orthopaedic surgeries (foot)Device: Orthopaedic surgeriesDevice: Orthopaedic surgeries (knee)Device: Orthopaedic surgeries (ankle)Device: Orthopaedic surgeries (shoulder)
- Registration Number
- NCT06532929
- Lead Sponsor
- Teknimed
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PINS foot surgery Orthopaedic surgeries (foot) Patients included for foot surgery with PINS SUTUR'LINK surgery Orthopaedic surgeries Patients included for surgery with SUTUR'LINK EUROSCREW NG PLA/TCP knee (PCL) surgery Orthopaedic surgeries (knee) Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP EUROSCREW NG PLA ankle surgery Orthopaedic surgeries (ankle) Patients included for ankle surgery with EUROSCREW NG PLA EUROSCREW PLA/TCP knee (ACL) surgery Orthopaedic surgeries (knee) Patients included for anterior crucial ligament of knee surgery with EUROSCREW PLA/TCP EUROSCREW NG PLA knee (PCL) surgery Orthopaedic surgeries (knee) Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA A'LINK'S shoulder surgery Orthopaedic surgeries (shoulder) Patients included for shoulder surgery with A'LINK'S EUROSCREW PLA knee (ACL) surgery Orthopaedic surgeries (knee) Patients included for anterior crucial ligament of knee surgery with EUROSCREW PLA EUROSCREW NG PLA/TCP knee (ACL) surgery Orthopaedic surgeries (knee) Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP A'LINK'S ankle surgery Orthopaedic surgeries (ankle) Patients included for ankle surgery with A'LINK'S EUROSCREW NG PLA knee (ACL) surgery Orthopaedic surgeries (knee) Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA ISOFIX knee (ACL) surgery Orthopaedic surgeries (knee) Patients included for anterior crucial ligament of knee surgery with ISOFIX
- Primary Outcome Measures
Name Time Method Evaluation of join function 4 years (until the lifetime of the device) 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
Adverse event 5 years Adverse event related to sports surgery products
- Secondary Outcome Measures
Name Time Method Quality of patient life 4 years 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)
Pain level 4 years 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
Antalgic consumption 4 years Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Patients' satisfaction 4 years Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
Radiological outcomes 4 years Evaluation of implants integrity/ resorption Bioresorbable screws, pins and anchors will be classified as "degraded", "partially intact" or "intact", as observed on imaging exam.
Devices and instrumentations usability Once, during surgery 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).
Trial Locations
- 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