Cuff Rotator SyndromeREGENECUFFNCT06269965
Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair
A study testing Regeneten® adding in people with Cuff Rotator Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cuff Rotator Syndrome
- What is being tested?
- Regeneten® adding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2024to 31 Oct 2028
- 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
- Patient, male or female, aged ≥ 18 years
- Patient candidate for rotator cuff repair affecting supraspinatus tendon (distal lesion) +/- infraspinatus on a non-pseudo-paralytic shoulder +/- proximal lesion of subscapularis
- Patient with GI ≤ 2 for each muscle
- Non-smoking patient
- Patient who is not involved in a work accident
- Patient candidate for total rotator cuff repair completely covering the footprint during surgery
Who cannot join
- Patient with contraindication to MRI
- Patient operated for cuff revision
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
Hôpital Privé Jean Mermoz
Lyon, 69008
Arnaud GODENECHE, MD, arnaud.godeneche@wanadoo.fr
About this study
Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream.
Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired.
Read more
Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.
In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing.
Read the detailed description
Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. They are located at the head of arm bone (humerus) and cover it, hence the name "cap".
Shoulder tendon injuries occur following sport's trauma, microtraumas often falling within the framework of musculoskeletal disorders (MSD) and heavy professional practices, or they are more simply due to body natural aging.
Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level (part of humerus where the supraspinatus and infraspinatus tendons insert) or a few centimeters in upstream. This disinsertion creates a passage between glenohumeral joint and subacromial space. Subsequently, rupture can extend forwards or backwards (which is the most common frequent case).
Rotator cuff surgery is an increasingly popular procedure practiced in France. Regardless of technical progress allowing today an ambulatory arthroscopic surgery, its success comes also from better knowledge of its indications and its clinical and histological results.
Overall, in limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired. Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study (NCT04444076) was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed at one year follow-up a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.
In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing.
- Conditions
- Cuff Rotator Syndrome
- Being tested
- Regeneten® adding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regeneten® addingDevice
Arthroscopic shoulder repair, in double row, with complete coverage of the foot print and addition of Regeneten®
| Study group | Role | What they receive |
|---|---|---|
| Regeneten® Arm | Experimental | Arthroscopic shoulder repair, in double row, with complete coverage of the foot print and addition of Regeneten® Receives: Device: Regeneten® adding |
| Witness Arm | No intervention | Arthroscopic shoulder repair, in double row, with complete coverage of the foot print |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff healing quality
Rotator cuff healing quality is evaluated with classification of Sugaya varying from type I to type V (performed from MRI) :
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
Measured: Year one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start23 Apr 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Rotator SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269965
- Sponsor's protocol ID
- 2023-A02181-44
- Acronym
- REGENECUFF
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair
- ClinicalTrials.gov ID
- NCT06269965
- Acronym / sponsor ID
- REGENECUFF / 2023-A02181-44
- Conditions
- Cuff Rotator Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 21 Feb 2024 (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 refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream.
Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired.
Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.
In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing.
Detailed description
Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. They are located at the head of arm bone (humerus) and cover it, hence the name "cap".
Shoulder tendon injuries occur following sport's trauma, microtraumas often falling within the framework of musculoskeletal disorders (MSD) and heavy professional practices, or they are more simply due to body natural aging.
Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level (part of humerus where the supraspinatus and infraspinatus tendons insert) or a few centimeters in upstream. This disinsertion creates a passage between glenohumeral joint and subacromial space. Subsequently, rupture can extend forwards or backwards (which is the most common frequent case).
Rotator cuff surgery is an increasingly popular procedure practiced in France. Regardless of technical progress allowing today an ambulatory arthroscopic surgery, its success comes also from better knowledge of its indications and its clinical and histological results.
Overall, in limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired. Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study (NCT04444076) was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed at one year follow-up a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.
In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regeneten® Arm | Experimental | Device: Regeneten® addingArthroscopic shoulder repair, in double row, with complete coverage of the foot print and addition of Regeneten® |
| Witness Arm | No intervention | –Arthroscopic shoulder repair, in double row, with complete coverage of the foot print |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient, male or female, aged ≥ 18 years
- Patient candidate for rotator cuff repair affecting supraspinatus tendon (distal lesion) +/- infraspinatus on a non-pseudo-paralytic shoulder +/- proximal lesion of subscapularis
- Patient with GI ≤ 2 for each muscle
- Non-smoking patient
- Patient who is not involved in a work accident
Key exclusion criteria (2 listed)
- Patient with contraindication to MRI
- Patient operated for cuff revision
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 |
|---|---|---|
| Regeneten® addingArthroscopic shoulder repair, in double row, with complete coverage of the foot print and addition of Regeneten® | Device | Regeneten® Arm |
Primary outcome
Rotator cuff healing quality
Time frame: Year one
Rotator cuff healing quality is evaluated with classification of Sugaya varying from type I to type V (performed from MRI) : 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
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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 Regeneten® adding in people with Cuff Rotator Syndrome, 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 6 inclusion and 2 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 20 Aug 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 Arnaud GODENECHE, MD (+ 33 4 37 53 00 24, arnaud.godeneche@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff healing quality (time frame: Year one). 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 20 Aug 2026.