Rotator Cuff Tears of the ShoulderNCT07448584
Lok™ Suture Anchors Safety & Performance Trial
A study testing Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion and Shoulder instability repair in people with Rotator Cuff Tears of the Shoulder and Labrum Injury, run by Move Up SAS at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears of the Shoulder, Labrum Injury
- What is being tested?
- Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion and Shoulder instability repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Alixan
Valence, Auvergne-Rhône-Alpes, 26300
Arnaud Thevenin, Directeur Qualité Affaires Rég, 33 660 883 369, arnaud.thevenin@move-ortho.com
About this study
Official title: 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).
- Conditions
- Rotator Cuff Tears of the Shoulder, Labrum Injury
- Being tested
- Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator cuff lesions repair combined to a long head of biceps pathologyProcedure or surgery
Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),
PASTA lesionProcedure or surgery
partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair
Shoulder instability repairProcedure or surgery
Gleno-humeral instabilities (Bankart lesion, SLAP lesion)
| Study group | Role | What they receive |
|---|---|---|
| Move-Up arm | Experimental | lok™ suture anchors range and associated instrumentation Receives: Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology; Procedure: PASTA lesion; Procedure: Shoulder instability repair |
| Routine care | Active comparator | Anchors and Ancillairies already CE marked (control arm) and used in routine care Receives: Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology; Procedure: PASTA lesion; Procedure: Shoulder instability repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the final follow up at 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the final follow up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start5 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tears of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Move Up SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448584
- Sponsor's protocol ID
- lok01
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07448584
- Acronym / sponsor ID
- lok01
- Conditions
- Rotator Cuff Tears of the Shoulder, Labrum Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Move Up SASIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Move-Up arm | Experimental | Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology, Procedure: PASTA lesion, Procedure: Shoulder instability repairlok™ suture anchors range and associated instrumentation |
| Routine care | Active comparator | Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology, Procedure: PASTA lesion, Procedure: Shoulder instability repairAnchors and Ancillairies already CE marked (control arm) and used in routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotator cuff lesions repair combined to a long head of biceps pathologyShoulder Gleno-humeral instability (Bankart lesion, SLAP lesion), | Procedure or surgery | Move-Up arm, Routine care |
| PASTA lesionpartial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair | Procedure or surgery | Move-Up arm, Routine care |
| Shoulder instability repairGleno-humeral instabilities (Bankart lesion, SLAP lesion) | Procedure or surgery | Move-Up arm, Routine care |
Primary outcome
Constant score
Time frame: From enrollment to the final follow up at 12 months
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.
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: From enrollment to the end of follow up at 12 months
Adverse Events (AEs)
Time frame: from enrollment to the final follow up at 12 months
Subjective Shoulder Value (SSV)
Time frame: From enrollment to the final follow up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion and Shoulder instability repair in people with Rotator Cuff Tears of the Shoulder and Labrum Injury, run by Move Up SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manal OUBOUKHA, Clinical affairs manager (33 677 096 697, manal.ouboukha@move-ortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant score (time frame: From enrollment to the final follow up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.