Lok™ Suture Anchors Safety & Performance Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMove Up SAS
About this trial
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed.
The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).
Eligibility criteria
Qualifiers
Consent to participate in the study: oral and written.
Man or woman over 18 years old with bone maturity finished.
Rotator cuff lesion (tear or calcific tendinopathy) associated to a pathology of the long head of the biceps,
Gleno-humeral instability,
Disqualifiers
None
Trial design
Treatments tested in this trial
- Rotator cuff lesions repair combined to a long head of biceps pathology
- PASTA lesion
- Shoulder instability repair
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov