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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rotator cuff lesions repair combined to a long head of biceps pathology
Procedure/SurgeryShoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),
PASTA lesion
Procedure/Surgerypartial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair
Shoulder instability repair
Procedure/SurgeryGleno-humeral instabilities (Bankart lesion, SLAP lesion)
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: Move-Up armExperimental treatment 3 interventions
Group B: Routine careActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Constant score
The functional improvement related to the implantation of these devices will be at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days with the primary endpoint being the Constant score.
Time frame
From enrollment to the final follow up at 12 monthsSecondary outcomes
1
Visual Analog Scale (VAS)
Evaluate the evolution of pain: This will be assessed using the Visual Analog Scale (VAS) for pain at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days.
Time frame
From enrollment to the end of follow up at 12 months2
Adverse Events (AEs)
Evaluate the safety of the lok™ system: Adverse Events (AEs) related to the devices will be collected at any time from the start of inclusion until 12 months after surgery.
Time frame
from enrollment to the final follow up at 12 months3
Subjective Shoulder Value (SSV)
Evaluation of the patient's subjective value with the Subjective Shoulder Value (SSV) at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days.
Time frame
From enrollment to the final follow up at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov