Health TrialsbyHealthPanel

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

ConditionSport Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTeknimed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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).

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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

Treatment groups

390 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: EUROSCREW NG PLA knee (ACL) surgery1 intervention
Group B: EUROSCREW NG PLA knee (PCL) surgery1 intervention
Group C: EUROSCREW NG PLA ankle surgery1 intervention
Group D: EUROSCREW NG PLA/TCP knee (ACL) surgery1 intervention
Group E: EUROSCREW NG PLA/TCP knee (PCL) surgery1 intervention
Group F: ISOFIX knee (ACL) surgery1 intervention
Group G: A'LINK'S shoulder surgery1 intervention
Group H: SUTUR'LINK surgery1 intervention
Group I: PINS foot surgery1 intervention

Trial outcomes

Primary outcomes

1

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)
2

Adverse event

Adverse event related to sports surgery products

Time frame
5 years

Secondary outcomes

1

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
2

Antalgic consumption

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

Time frame
4 years
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Teknimed

Lead sponsor

Source ClinicalTrials.gov
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