NCT07448584

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 15, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 26, 2026

Last Update Submit

April 14, 2026

Conditions

Rotator Cuff Tears of the ShoulderLabrum Injury

Outcome Measures

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.

    From enrollment to the final follow up at 12 months

Secondary Outcomes (3)

  • Visual Analog Scale (VAS)

    From enrollment to the end of follow up at 12 months

  • Adverse Events (AEs)

    from enrollment to the final follow up at 12 months

  • Subjective Shoulder Value (SSV)

    From enrollment to the final follow up at 12 months

Study Arms (2)

Move-Up arm

EXPERIMENTAL

lok™ suture anchors range and associated instrumentation

Procedure: Rotator cuff lesions repair combined to a long head of biceps pathologyProcedure: PASTA lesionProcedure: Shoulder instability repair

Routine care

ACTIVE COMPARATOR

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 pathologyProcedure: PASTA lesionProcedure: Shoulder instability repair

Interventions

Rotator cuff lesions repair combined to a long head of biceps pathologyPROCEDURE

Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),

Move-Up armRoutine care
PASTA lesionPROCEDURE

partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair

Move-Up armRoutine care
Shoulder instability repairPROCEDURE

Gleno-humeral instabilities (Bankart lesion, SLAP lesion)

Move-Up armRoutine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alixan

Valence, Auvergne-Rhône-Alpes, 26300, France

RECRUITING

Central Study Contacts

Manal OUBOUKHA, Clinical affairs manager

CONTACT

33 677 096 697manal.ouboukha@move-ortho.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-02

Locations

FR(1)