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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:
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:
And following associated TEKNIMED instrumentation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUROSCREW NG PLA knee (ACL) surgery | Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA |
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| EUROSCREW NG PLA knee (PCL) surgery | Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA |
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| EUROSCREW NG PLA ankle surgery | Patients included for ankle surgery with EUROSCREW NG PLA |
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| EUROSCREW NG PLA/TCP knee (ACL) surgery | Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP |
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| EUROSCREW NG PLA/TCP knee (PCL) surgery | Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA/TCP |
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| ISOFIX knee (ACL) surgery | Patients included for anterior crucial ligament of knee surgery with ISOFIX |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthopaedic surgeries (ankle) | Device | ankle lateral ligament reconstruction in ligamentoplasty procedures |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
For prospective inclusion:
- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.
For retrospective inclusion:
Exclusion Criteria:
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People suffering from tears or ruptures of ligaments or tendons and in need of an orthopaedic surgery, according to the specific intended uses related to each device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Solange VAN DE MOORTELE, PhD | Contact | +33 5 34 25 26 79 | s.vandemoortele@teknimed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milaire | Not yet recruiting | Aubenas | Ardèche | 07200 | France |
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| A'LINK'S shoulder surgery | Patients included for shoulder surgery with A'LINK'S |
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| SUTUR'LINK surgery | Patients included for surgery with SUTUR'LINK |
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| PINS foot surgery | Patients included for foot surgery with PINS |
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| Orthopaedic surgeries (shoulder) | Device | rotator cuff repair |
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| Orthopaedic surgeries (knee) | Device | knee cruciate ligaments reconstruction in ligamentoplasty procedures |
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| Orthopaedic surgeries | Device | rotator cuff repair or closure of capsule after arthroplasty surgery |
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| Orthopaedic surgeries (foot) | Device | stabilization of metatarsal and phalangeal osteotomies during treatment of hallux |
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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 |
| Centre Claude Bernard | Recruiting | Guilherand-Granges | Ardèche | 07500 | France |
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| Centre Mistral -Clinique Pasteur | Recruiting | Guilherand-Granges | Ardèche | 07500 | France |
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| Orthopole des 3 provinces | Recruiting | Brive-la-Gaillarde | Corrèze | 19100 | France |
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| Clinique Pasteur | Recruiting | Bergerac | Dordogne | 24100 | France |
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| Médipôle Toulouse | Recruiting | Toulouse | Haute-Garonne | 31100 | France |
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| Clinique Chénieux | Completed | Limoges | Haute-Vienne | 87000 | France |
| Clinique St Privat | Recruiting | Boujan-sur-Libron | Hérault | 34760 | France |
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| Clinique Via Domitia | Active, not recruiting | Lunel | Hérault | 34400 | France |
| Clinique Esquirol Saint-Hilaire | Recruiting | Agen | Lot-et-Garonne | 47000 | France |
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