Rotator Cuff DisordersEPIMARGENCT07838922
Long-term Clinical and Anatomical Evaluation of Edge-to-edge Repair of Large to Very Large Rotator Cuff Tears
A study testing MRI in people with Rotator Cuff Disorders, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Disorders
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 31 Oct 2029
- 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
- Patients, male or female, aged 18 or over at the time of surgery
- Patients who underwent a edge-to-edge surgical repair of the rotator cuff between 2015 and 2017 at Jean Mermoz Hospital in Lyon (including patients who had previously undergone a first rotator cuff repair)
- Patients with a V-shaped, retracted supraspinatus tendon tear, with or without involvement of the infraspinatus tendon, rendering direct reattachment of the tendon to the bone impossible
- Patients for whom pre-operative and operative records are available
- Patients agreeing to long-term follow-up comprising clinical assessment and an MRI scan
- Patients affiliated with or covered by a social security scheme
- French-speaking patients who have signed an informed consent form
Who cannot join
- Patients who have undergone conventional tendon-to-bone repair rather than edge-to-edge repair
- Patients with significant subscapularis tendon lesions requiring specific repair
- Patients with massive or irreparable concomitant rotator cuff tears unsuitable for edge-to-edge repair
- Patient with a history of previous shoulder surgery on the affected side, other than rotator cuff surgery
- Patient with severe glenohumeral osteoarthritis or another shoulder condition that may skew the results
- Patient with a contraindication to MRI
Show all 9Show fewer
- Patients under legal protection: adults under guardianship, curatorship or other legal protection; or those deprived of their liberty by a judicial or administrative decision
- Patients admitted to hospital without consent
- Pregnant women.
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
Hôpital Privé Jean Mermoz
Lyon, 69008
Laurent NOVE JOSSERAND, MD, + 33 437530022, laurent.nove-josserand@wanadoo.fr
About this study
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed.
Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent and many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
Read the detailed description
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears, which may present with signs and symptoms of varying severity. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed. This is therefore a specific indication that fits between standard anatomical repairs (tendon-to-bone), partial repairs that are deliberately incomplete, and tendon transfers, for which the indications are very specific.
Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent. Beyond comparisons of clinical outcomes, patient-reported outcomes have also been insufficiently studied in relation to the MC technique. Furthermore, long-term follow-up after rotator cuff repair surgery is essential to assess structural deterioration, the progression of osteoarthritis or arthropathy, and the occurrence of delayed functional decline. However, many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
- Conditions
- Rotator Cuff Disorders
- Being tested
- MRI
- Keywords
- Rotator cuff disorder, edge-to-edge suturing, complete break in the tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Intervention is an MRI scan of the rotator cuff with a minimum follow-up period of 10 years following a edge-to-edge surgical repair.
| Study group | Role | What they receive |
|---|---|---|
| Edge-to-edge suturing arm | Experimental | An MRI (Magnetic Resonance Imaging) scan of the rotator cuff is performed in patients with a minimum follow-up period of 10 years following a edge-to-edge surgical repair for a rotator cuff tear involving the supraspinatus and/or infraspinatus tendons Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugaya classification
The Sugaya classification is a 5-point system used to evaluate rotator cuff repair :
Type I: sufficient thickness compared to normal cuff with homogeneous low signal Type II: sufficient thickness compared to normal cuff with partial high-intensity area Type III: <50% thickness compared to normal cuff without discontinuity suggests partial-thickness delamination tear Type IV: minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images suggests small full-thickness tear Type V: major discontinuity (>2 slices) on both oblique coronal and sagittal images suggests medium or large full-thickness tear
Tendon healing is defined by types I, II and III.
Measured: 10 years
Secondary outcomes (5)
Modified Goutallier-Fuchs classification
Modified Goutallier-Fuchs classification i sused to measure fat infiltration within the supraspinatus and/or infraspinatus
Measured: 10 years
Constant score
Constant score will measure the functional impact of injuries to supraspinatus and/or infraspinatus muscles
Measured: Baseline and 10 years
SSV (Subjective Shoulder Value)
SSV will assess patients' subjective experience
Measured: Baseline and 10 years
VAS (Visual Analog Score)
VAS will measure patient pain
Measured: Baseline and 10 years
Likert scale
A 4-item Likert scale will measure patient satisfaction
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DisordersStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838922
- Sponsor's protocol ID
- 2026-A01261-50
- Acronym
- EPIMARGE
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical and Anatomical Evaluation of Edge-to-edge Repair of Large to Very Large Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT07838922
- Acronym / sponsor ID
- EPIMARGE / 2026-A01261-50
- Conditions
- Rotator Cuff Disorders
- Keywords
- Rotator cuff disorder, edge-to-edge suturing, complete break in the tendon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 24 Sep 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.
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed.
Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent and many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
Detailed description
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears, which may present with signs and symptoms of varying severity. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed. This is therefore a specific indication that fits between standard anatomical repairs (tendon-to-bone), partial repairs that are deliberately incomplete, and tendon transfers, for which the indications are very specific.
Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent. Beyond comparisons of clinical outcomes, patient-reported outcomes have also been insufficiently studied in relation to the MC technique. Furthermore, long-term follow-up after rotator cuff repair surgery is essential to assess structural deterioration, the progression of osteoarthritis or arthropathy, and the occurrence of delayed functional decline. However, many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edge-to-edge suturing arm | Experimental | Other: MRIAn MRI (Magnetic Resonance Imaging) scan of the rotator cuff is performed in patients with a minimum follow-up period of 10 years following a edge-to-edge surgical repair for a rotator cuff tear involving the supraspinatus and/or infraspinatus tendons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients, male or female, aged 18 or over at the time of surgery
- Patients who underwent a edge-to-edge surgical repair of the rotator cuff between 2015 and 2017 at Jean Mermoz Hospital in Lyon (including patients who had previously undergone a first rotator cuff repair)
- Patients with a V-shaped, retracted supraspinatus tendon tear, with or without involvement of the infraspinatus tendon, rendering direct reattachment of the tendon to the bone impossible
- Patients for whom pre-operative and operative records are available
- Patients agreeing to long-term follow-up comprising clinical assessment and an MRI scan
Key exclusion criteria (9 listed)
- Patients who have undergone conventional tendon-to-bone repair rather than edge-to-edge repair
- Patients with significant subscapularis tendon lesions requiring specific repair
- Patients with massive or irreparable concomitant rotator cuff tears unsuitable for edge-to-edge repair
- Patient with a history of previous shoulder surgery on the affected side, other than rotator cuff surgery
- Patient with severe glenohumeral osteoarthritis or another shoulder condition that may skew the results
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 |
|---|---|---|
| MRIIntervention is an MRI scan of the rotator cuff with a minimum follow-up period of 10 years following a edge-to-edge surgical repair. | Other | Edge-to-edge suturing arm |
Primary outcome
Sugaya classification
Time frame: 10 years
The Sugaya classification is a 5-point system used to evaluate rotator cuff repair : Type I: sufficient thickness compared to normal cuff with homogeneous low signal Type II: sufficient thickness compared to normal cuff with partial high-intensity area Type III: <50% thickness compared to normal cuff without discontinuity suggests partial-thickness delamination tear Type IV: minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images suggests small full-thickness tear Type V: major discontinuity (>2 slices) on both oblique coronal and sagittal images suggests medium or large full-thickness tear Tendon healing is defined by types I, II and III.
5 secondary outcomes
Modified Goutallier-Fuchs classification
Time frame: 10 years
Constant score
Time frame: Baseline and 10 years
SSV (Subjective Shoulder Value)
Time frame: Baseline and 10 years
VAS (Visual Analog Score)
Time frame: Baseline and 10 years
Likert scale
Time frame: 10 years
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 24 Sep 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 MRI in people with Rotator Cuff Disorders, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Sep 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 Laurent NOVE JOSSERAND, MD (+ 33 4 37 53 00 24, laurent.nove-josserand@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sugaya classification (time frame: 10 years). 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 24 Sep 2026.