Rotator Cuff InjuriesRePaReNCT06857084
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
An observational study of Rotator Cuff Injuries, run by Smith & Nephew, Inc. at 22 sites in 4 countries.
Trial summary
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 1 Oct 2020to 31 Dec 2029
- How long will I take part?
- 7 Years
- Phase
- Observational
- 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
Study population: Orthopaedic Clinics/practices
Who may be able to join
- Subject requires Arthroscopic rotator cuff repair (ARCR);
- Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.
Who cannot join
- Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.
- Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
- Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
Trial locations and contacts
22 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 4 countries
United Kingdom11 sites, 11 recruiting
- Recruiting
Sulis Hospital Bath
Bath, Somerset, BA2 8SF
Andrew Chambler, +44 (0)1761 422288, andrew.chambler@sulishospital.com
Andrew Chambler
- Recruiting
Spire Montefiore
Brighton, Hove, BN3 1RD
Cameron Hatrick, +44 (0) 127 392 0229, cameron.hatrick@nhs.net
Cameron Hatrick
- Recruiting
Burnley General Hospital
Burnley, Lancashire, BB10 2PQ
Saif Hadi, +44 (0)1254 734165, saif.hadi@elht.nhs.uk
Saif Hadi
- Recruiting
Burnley General Teaching Hospital
Burnley, Lancashire, BB10 2PQ
Marakam Srinivasan, +39 080 3054111, Makaram.Srinivasan@elht.nhs.uk
Marakam Srinivasan
- Recruiting
Grantham and District Hospital
Grantham, Lincolnshire, NG31 8DG
Alun Yewlett, alun.yewlett@ulh.nhs.uk
Alun Yewlett
- Recruiting
Spire Harpenden Hospital
Harpenden, Hertordshire, AL5 4BP
Tony Corner, +44 (0) 808 239 8214, amanda.laws@spirehealthcare.com
Tony Corner
- Not yet recruiting
West Hertfordshire Hospitals NHS Trust
Hertford
Tressa Amirthanayagam, 0, catherine.whittall@smith-nephew.com
Tressa Amirthanayagam
- Recruiting
University College London Hospitals
London, London, NW1 2BU
Tanujan Thangarajah
+44 (0) 20 3456 7890, tanujan.thangarajah@doctors.org.uk
- Recruiting
Cleveland Clinic London Hospital
London, London, SW1X 7HY
Philip Ahrens, +44 (0)20 3423 7500, pahrens@doctors.org.uk
Philip Ahrens
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Mustafa Rashid, +44 (0)1254 734165, mustafa.rashid@icloud.com
Mustafa Rashid
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Lancashire, M23 9LT
Chris Peach, +44 (0) 161 447 6865, c.peach@doctors.org.uk
Chris Peach
Germany7 sites, 7 recruiting
- Recruiting
Schoen Klinik Dusseldorf
Düsseldorf, 40549
Thilo Patzer, +49 211 5670, tpatzer@schoen-kliniken.de
Thilo Patzer
- Recruiting
Malteser Waldkrankenhaus Erlangen
Erlangen, 91054
Thomas Tischer, +49 9131 8220, thomas.tischer@waldkrankenhaus.de
Thomas Tischer
- Recruiting
Sporthopaedie Heidelberg
Heidelberg, 69121
Michael Koch, +49 6221 649090, michaeljankoch@gmail.com
Michael Koch
- Recruiting
St. Anna Hospital
Herne, 44649
Roderich Heikenfeld, +49 2325 9860, roderich.heikenfeld@elisabethgruppe.de
Roderich Heikenfeld
- Recruiting
Schoen Klinik Lorsch
Lorsch, Rhine, 64653
Olaf Lorbach, +49 89 2872410, olorbach@schoen-klinik.de
Olaf Lorbach
- Recruiting
Artemed Klinikum München Süd
München, 81379
Florian Haasters, Prof. Dr., 0, florian.haasters@artemed.de
Florian Haasters, Prof. Dr.
- Recruiting
OrthoMedicum Mittelhessen
Stadtallendorf, 35260
Bilal El-Zayat, +49 6428 9266464, el-zayat@orthomedicum-mittelhessen.de
Bilal El-Zayat
Italy3 sites, 3 recruiting
- Recruiting
Regional General Hospital F. Miulli
Acquaviva delle Fonti, Apulia, 70021
Anna De Luca, +39 080 3054111, a.deluca@miulli.it
Raffaele Garofalo
- Recruiting
Ospedale Israelitico
Roma
Roberto Postacchini, +393791663290, catherine.whittall@smith-nephew.com
Roberto Postacchini
- Recruiting
Ospedale di Sassuolo
Sassuolo, 41049
Giuseppe Porcellini, +39 3356289858, catherine.whittall@smith-nephew.com
Giuseppe Porcellini
Australia1 site, 1 recruiting
- Recruiting
Melbourne Orthopaedic Group
Windsor, Victoria, 3181
Shane Barwood, +61 (0)3 9525 1035, shane@barwood.net.au
Shane Barwood
About this study
Official title: Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation.
Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
- Keywords
- Rotator Cuff Repair, Rotator Cuff Tear, Full Thickness Tear, Partial Thickness Tear, Massive Tear, REGENETEN Bioinductive Implant
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentationDevice
Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff repair using REGENETEN | Patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant Receives: Device: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
Quick DASH (Disabilities of Arm, Shoulder and Hand) is designed to measure physical function and symptoms. It assesses 11 items, with scores ranging from 0 to 100 where 0 indicates no disability (i.e., better outcome) and 100 indicates most severe disability (i.e., worse outcome).
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems).
The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Pain, Visual Analog Scale (VAS) Score
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable
Measured: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
Single Assessment Numeric Evaluation (SANE) Score
The Single Assessment Numeric Evaluation (SANE) is a simple but effective measure where patients rate their shoulder condition as a percentage (0-100%), where 100% being completely normal and 0% being the worst condition imaginable.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcomes (3)
Retear Rate
Cumulative 3 months, 6 months, 12 months, and 24 months retear rate. Failure is defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Measured: 3 months, 6 months, 12 months, and 24 months
Post-operative Recovery: Sling Type and Mobilization Time
The type of sling will be collected and presented for each treatment arm summarizing if standard sling, shoulder immobilizer, abduction sling, ER sling, or other were advised. Mobilization time will be calculated for both arms.
Measured: 2 weeks
Post-operative Recovery: Return to Work
Return to work questionnaires are collected at baseline and at 6 months post-op.
At baseline, information on working arrangements are established:
- Occupation status: Full time/part time/ retired
- Occupation type: Sedentary/labor intensive
- Impact of their diagnosis on their work performance: negative impact/no change
At 6 months, information on changes to working arrangements is established:
- Changes to occupation status
- Returned to work and at what level: not returned due to procedure, not returned for other reasons, retired, lower level, same level, higher level
- Time taken to return to work in days/weeks/months (if applicable)
Measured: Baseline and 6 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 2025
- Study start1 Oct 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 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 InjuriesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Lynch, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857084
- Sponsor's protocol ID
- REGENETEN Global Registry
- Acronym
- RePaRe
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry
- ClinicalTrials.gov ID
- NCT06857084
- Acronym / sponsor ID
- RePaRe / REGENETEN Global Registry
- Conditions
- Rotator Cuff Injuries
- Keywords
- Rotator Cuff Repair, Rotator Cuff Tear, Full Thickness Tear, Partial Thickness Tear, Massive Tear, REGENETEN Bioinductive Implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Mar 2025 (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.
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation.
Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff repair using REGENETEN | – | Device: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentationPatients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic Clinics/practices
Key inclusion criteria (2 listed)
- Subject requires Arthroscopic rotator cuff repair (ARCR);
- Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.
Key exclusion criteria (3 listed)
- Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.
- Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
- Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
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 |
|---|---|---|
| Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentationArthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. | Device | Rotator cuff repair using REGENETEN |
Primary outcome
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Quick DASH (Disabilities of Arm, Shoulder and Hand) is designed to measure physical function and symptoms. It assesses 11 items, with scores ranging from 0 to 100 where 0 indicates no disability (i.e., better outcome) and 100 indicates most severe disability (i.e., worse outcome).
Oxford Shoulder Score (OSS)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Pain, Visual Analog Scale (VAS) Score
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable
Single Assessment Numeric Evaluation (SANE) Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The Single Assessment Numeric Evaluation (SANE) is a simple but effective measure where patients rate their shoulder condition as a percentage (0-100%), where 100% being completely normal and 0% being the worst condition imaginable.
3 secondary outcomes
Retear Rate
Time frame: 3 months, 6 months, 12 months, and 24 months
Post-operative Recovery: Sling Type and Mobilization Time
Time frame: 2 weeks
Post-operative Recovery: Return to Work
Time frame: Baseline and 6 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 1 Jun 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.
Peter Lynch study director
Smith & Nephew, Inc.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries, run by Smith & Nephew, Inc. at 22 sites in 4 countries.
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 2 inclusion and 3 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Germany, Italy, Australia. 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 Cat Whittall (+44 7841868997, catherine.whittall@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months). The study lists 5 primary outcomes in all. 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 1 Jun 2026.