Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06532929

Sport Surgery Products Outcomes - A Post-market Follow-up

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sport Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Milaire, Aubenas, Ardèche, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthopaedic surgeries (ankle)

Device

ankle lateral ligament reconstruction in ligamentoplasty procedures

Orthopaedic surgeries (shoulder)

Device

rotator cuff repair

Orthopaedic surgeries (knee)

Device

knee cruciate ligaments reconstruction in ligamentoplasty procedures

Orthopaedic surgeries

Device

rotator cuff repair or closure of capsule after arthroplasty surgery

Orthopaedic surgeries (foot)

Device

stabilization of metatarsal and phalangeal osteotomies during treatment of hallux

Primary outcomes

  1. Evaluation of join function

    Time frame: 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

  2. Adverse event

    Time frame: 5 years

    Adverse event related to sports surgery products

Secondary outcomes

  1. Pain level

    Time frame: 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

  2. Antalgic consumption

    Time frame: 4 years

    Antalgic consumption and the drug type at the Baseline and at the Follow-up visits

  3. Patients' satisfaction

    Time frame: 4 years

    Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits

  4. Quality of patient life

    Time frame: 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)

  5. Radiological outcomes

    Time frame: 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.

  6. Devices and instrumentations usability

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Solange VAN DE MOORTELE, PhD

CONTACT

[email protected]

+33 5 34 25 26 79

Sponsors and collaborators

Lead sponsor

Teknimed

Industry

Registry information

Official study title

Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up

Important dates

Study start
2019
Primary completion
2036
Study completion
2036
First posted
Aug 1, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.