Clinical trial NCT06532929: Sport Surgery Products Outcomes - A Post-market Follow-up
Official title: Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sport Surgery
Keywords: knee
shoulder
sport
surgery
suture
ligamentoplasty
anchors
screw
resorbable
pins
Lead sponsor: Teknimed
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of join function
timeFrame: 4 years (until the lifetime of the device)
measure: Adverse event
timeFrame: 5 years
Secondary outcomes:
measure: Pain level
timeFrame: 4 years
measure: Antalgic consumption
timeFrame: 4 years
measure: Patients' satisfaction
timeFrame: 4 years
measure: Quality of patient life
timeFrame: 4 years
measure: Radiological outcomes
timeFrame: 4 years
measure: Devices and instrumentations usability
timeFrame: Once, during surgery
Other outcomes:
Locations:
city: Aubenas
country: France
facility: Milaire
state: Ardèche
city: Guilherand-Granges
country: France
facility: Centre Claude Bernard
state: Ardèche
city: Guilherand-Granges
country: France
facility: Centre Mistral -Clinique Pasteur
state: Ardèche
city: Brive-la-Gaillarde
country: France
facility: Orthopole des 3 provinces
state: Corrèze
city: Bergerac
country: France
facility: Clinique Pasteur
state: Dordogne
city: Toulouse
country: France
facility: Médipôle Toulouse
state: Haute-Garonne
city: Limoges
country: France
facility: Clinique Chénieux
state: Haute-Vienne
city: Boujan-sur-Libron
country: France
facility: Clinique St Privat
state: Hérault
city: Lunel
country: France
facility: Clinique Via Domitia
state: Hérault
city: Agen
country: France
facility: Clinique Esquirol Saint-Hilaire
state: Lot-et-Garonne
Study officials:
References: