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
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 design
Treatments tested in this trial
- Orthopaedic surgeries (ankle)
- Orthopaedic surgeries (shoulder)
- Orthopaedic surgeries (knee)
- Orthopaedic surgeries
- Orthopaedic surgeries (foot)
Treatment groups
390 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov