Lok™ Suture Anchors Safety & Performance Trial

Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical 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).

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears of the Shoulder; Labrum Injury
• Intervention / Treatment: Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology; Procedure: PASTA lesion; Procedure: Shoulder instability repair

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manal OUBOUKHA, Clinical affairs manager; Phone Number: 33 677 096 697; Email: manal.ouboukha@move-ortho.com

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Valence, Auvergne-Rhône-Alpes, France, 26300
      • Recruiting
      • Alixan
      • Contact: Arnaud Thevenin, Directeur Qualité Affaires Rég; Phone Number: 33 660 883 369; Email: arnaud.thevenin@move-ortho.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Consent to participate in the study: oral and written.
• Man or woman over 18 years old with bone maturity finished.

• Presented with one of the following indications:

  • Rotator cuff lesion (tear or calcific tendinopathy) associated to a pathology of the long head of the biceps,
  • Gleno-humeral instability,
  • partial articular-sided tendon avulsion [PASTA] lesion.
• MRI or arthrogram proving the rotator cuff lesion and long head of the biceps tendon injury, or the labrum injury, or PASTA injury.

Non inclusion Criteria:

• Radiographic sign of fracture: glenoid or lesser tuberosity.
• Major trauma to the shoulder joint.
• Any active infection or avascular necrosis.
• Inflammatory joint disease.
• Moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4).
• Bone pathologies compromising anchorage (cystic changes, severe osteopenia).
• Pathological conditions of soft tissues impairing suture fixation.
• Known hypersensitivity to implant material (PEEK and carbon or Polyethylene).
• Anterior ipsilateral surgeries performed on the joint space.
• Physical conditions that would eliminate, or tend to eliminate, adequate anchoring support or delay healing.
• Contraindications from the instructions for use of the medical devices used.
• Conditions that would limit the subject's ability or willingness to restrict activities or follow instructions during the healing period.
• Inability to complete questionnaires: language problems, who do not speak/read/understand French.
• Pregnant or breastfeeding women.
• Persons deprived of liberty or under guardianship.
• Patients unable to undergo medical monitoring of the trial.
• Psychiatric illnesses, cognitive disorders, or health problems that prevent informed consent.
• Participation in another clinical trial.
• Life expectancy of less than 12 months.
• No health insurance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Move-Up arm; lok™ suture anchors range and associated instrumentation	Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology; Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),; Procedure: PASTA lesion; partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair; Procedure: Shoulder instability repair; Gleno-humeral instabilities (Bankart lesion, SLAP lesion)
Active Comparator: Routine care; Anchors and Ancillairies already CE marked (control arm) and used in routine care	Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology; Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),; Procedure: PASTA lesion; partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair; Procedure: Shoulder instability repair; Gleno-humeral instabilities (Bankart lesion, SLAP lesion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the final follow up at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of follow up at 12 months
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.	from enrollment to the final follow up at 12 months
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.	From enrollment to the final follow up at 12 months

Collaborators and Investigators

• Sponsor: Move Up SAS

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: lok01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No