Rotator Cuff InjuriesREGENETENNCT04450342
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
A study testing Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair and Arthroscopic rotator cuff repair for revision surgery in people with Rotator Cuff Injuries, run by Smith & Nephew, Inc. at 30 sites in 8 countries.
Trial summary
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair and Arthroscopic rotator cuff repair for revision surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 7 Dec 2020to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject requires Arthroscopic rotator cuff repair (ARCR);
- Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (≥ 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a ≥ 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as ≥ 3 cm on arthroscopy using a calibrated probe to proceed;
- Subject is > 40 years of age (no upper limit);
- Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Who cannot join
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
- Subjects with Samilson-Prieto osteoarthritis > 2;
- Subjects with current or prior infection of the ipsilateral shoulder;
- Subjects with known hypersensitivity to bovine-derived materials;
- Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
- Subjects with prior shoulder surgery (not including rotator cuff repair [revision repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE], subacromial decompression);
Show all 20Show fewer
- Subjects with an irreparable or partially reparable rotator cuff tear;
- Subjects with a subscapularis tear requiring repair;
- Subjects requiring a concomitant labral fixation procedure;
- Subjects requiring a concomitant os acromiale fixation procedure;
- Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
- Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
- Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
- Subjects who are pregnant or breast feeding;
- Subjects who are currently involved in any injury litigation or workers compensation claims;
- Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study;
- Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation
- 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 study including mental illness, mental retardation, 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
30 sites in 8 countries.
30 sites in 8 countries
United States8 sites
Ashland Memorial Medical Center
Ashland, Wisconsin, 54806
Sinai Hospital
Baltimore, Maryland, 21215
Texas Orthopedic Specialists
Bedford, Texas, 76021-5011
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44125
Syracuse Orthopedic Specialists
DeWitt, New York, 13214
Harbin Clinic
Rome, Georgia, 30165
Houston Methodist The Woodlands
The Woodlands, Texas, 17201
United Kingdom8 sites
The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, West Midlands, B31 2AP
Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH
Southmead Hospital
Bristol, BS105NB
University Hospitals Coventry and Warwickshire
Coventry, Warwickshire, CV2 2DX
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L7 8XP
Nottingham University Hospital
Nottingham, Nottinghamshire, NG7 2UH
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, HA7 4LP
University Hospital of South Manchester NHS Foundation Trust
Wythenshawe, Manchester, M23 9LT
France5 sites
Clinique Saint-Jean - Montpellier
Montpellier, 34430
Hôpital Pasteur 2
Nice, Provence-Alpes-Côte d'Azur Region, 06000
Hôpital Ambroise Paré
Paris, Boulogne-Billancourt, 92100
Bichat Hospital
Paris, 75018
Hôpital Privé de l'Ouest Parisien
Trappes, Île-de-France Region, 78190
Canada3 sites
McMaster University
Hamilton, Ontario, L8N 4A6
Saint John Orthopaedics
Saint John, New Brunswick, E2K 4X2
Women's College Hospital Toronto
Toronto, Ontario, M5S 1B2
Australia2 sites
OrthoSport Victoria
Richmond, Victoria, 3121
Macquarie University Hospital
Sydney, New South Wales, 2109
Switzerland2 sites
Balgrist University Hospital
Zurich, 8008
Schulthess Klinik
Zurich, 8008
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
Read the detailed description
This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair, Arthroscopic rotator cuff repair for revision surgery
- Keywords
- Rotator cuff tendon, Full thickness tears, REGENETEN Bioinductive Implant System
- 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
The 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. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
Arthroscopic rotator cuff repairProcedure or surgery
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
Arthroscopic rotator cuff repair for revision surgeryDevice
The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
| Study group | Role | What they receive |
|---|---|---|
| ARCR augmented with REGENETEN™ Bioinductive Implant | Experimental | During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. Receives: Device: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation |
| ARCR alone | Sham comparator | The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing Receives: Procedure: Arthroscopic rotator cuff repair |
| Revision group | Other | Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN Receives: Device: Arthroscopic rotator cuff repair for revision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear Rate at 6 Months
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Measured: 6 months
Secondary outcomes (35)
Number of Retears at 3 Months, 12 Months, and 24 Months
Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Measured: 3 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, 3 months, 6 months, 12 months and 24 months
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Constant-Murley Score
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Subjective Shoulder Value (SSV)
The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for 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 participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Medical Care
The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.
Measured: Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
Measured: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
Measured: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
Measured: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses:
- Excellent
- Very Good
- Good
- Fair
- Poor
Measured: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses:
- Definitely Yes
- Probably Yes
- Possibly Not
- Definitely Not
Measured: 3 months, 6 months, 12 months and 24 months
Pain - Visual Analog Scale (VAS) Score
Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).
Measured: 2 weeks, 6 weeks, 3 months and 6 months
MRI Tendon Findings: Supraspinatus Sugaya Score
The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Measured: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Sugaya Score
The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Measured: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Supraspinatus Goutallier Classification
Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks.
Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following:
- Grade 0
- Grade I
- Grade 2
- Grade 3
- Grade 4
- Unable to assess
Measured: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Goutallier Classification
Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks.
Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following:
- Grade 0
- Grade I
- Grade 2
- Grade 3
- Grade 4
- Unable to assess
Measured: 3 months, 6 months, 12 months and 24 months
Total Tendon Thickness
Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).
Measured: 3 months, 6 months, 12 months and 24 months
Total Tendon Length
Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).
Measured: 3 months, 6 months, 12 months and 24 months
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
Area of retear in millimeters squared (mm^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Measured: Day 0, 3 months and 6 months
Size of Retear: Anteroposterior (AP) Length
Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Measured: Day 0, 3 months and 6 months
Size of Retear: Mediolateral (ML) Length
Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Measured: Day 0, 3 months and 6 months
Shape of Retear: Operative Visit
Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes:
- Crescent
- L Shape
- Reverse L
- U Shape
- Massive/Contracted
- Unable to Determine
Measured: Day 0
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes:
- Intact (i.e., no re-tear)
- Crescent
- Longitudinal
- Massive
- Unable to Determine
Measured: 3 months, 6 months, 12 months and 24 months
Return to Work Questionnaire
Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions:
- Returned to work?
- Have you been able to return to the job you did before your surgery?
- Did you feel ready to go back to work physically?
- Since returning to work, any time off due to shoulder pain or weakness?
- Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
Measured: 2 weeks, 6 weeks, 3 months and 6 months
Return to Work Questionnaire: Reason for Not Getting Back to Work
The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options:
- Physical capability
- Safety
- Motivation
- Other
Measured: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Reason Couldn't Return to Activities
The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options:
- Physical capability
- Safety
- Motivation
- Other
Measured: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Time Off
Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.
Measured: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Duration Away From Work (Days)
Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work
Measured: 2 weeks, 6 weeks, 3 months, 6 months
Duration of Opioid Use
Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Measured: Following surgery, up to 14 days
Opioid Use for More Than 5 Days Post-Surgery
Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Measured: Following surgery, up to 14 days
Total Operative Time
Total operative time in minutes.
Measured: Intraoperative
Sling Type
The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following:
- Standard Sling
- Shoulder Immobilizer
- Sling and Swathe
- Abduction Sling
- External Rotation Sling
- Other
- Missing
Measured: up to 3 months
Mobilization Time in Sling
Mobilization time was the duration, measured in weeks, that participants spent in a sling.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start7 Dec 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: Sponsor decision not related to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff InjuriesStudies 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
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Peach, MBBS MD FRCS (Tr&Orth), Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450342
- Sponsor's protocol ID
- REGENETEN.2020.01
- Acronym
- REGENETEN
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2020
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone
- ClinicalTrials.gov ID
- NCT04450342
- Acronym / sponsor ID
- REGENETEN / REGENETEN.2020.01
- Conditions
- Rotator Cuff Injuries
- Keywords
- Rotator cuff tendon, Full thickness tears, REGENETEN Bioinductive Implant System
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision not related to safety.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
Detailed description
This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARCR augmented with REGENETEN™ Bioinductive Implant | Experimental | Device: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentationDuring the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors. |
| ARCR alone | Sham comparator | Procedure: Arthroscopic rotator cuff repairThe rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing |
| Revision group | Other | Device: Arthroscopic rotator cuff repair for revision surgeryRevision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject requires Arthroscopic rotator cuff repair (ARCR);
- Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (≥ 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a ≥ 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as ≥ 3 cm on arthroscopy using a calibrated probe to proceed;
- Subject is > 40 years of age (no upper limit);
- Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Key exclusion criteria (20 listed)
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
- Subjects with Samilson-Prieto osteoarthritis > 2;
- Subjects with current or prior infection of the ipsilateral shoulder;
- Subjects with known hypersensitivity to bovine-derived materials;
- Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
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 augmentationThe 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. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | Device | ARCR augmented with REGENETEN™ Bioinductive Implant |
| Arthroscopic rotator cuff repairThe Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement. | Procedure or surgery | ARCR alone |
| Arthroscopic rotator cuff repair for revision surgeryThe Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure. | Device | Revision group |
Primary outcome
Retear Rate at 6 Months
Time frame: 6 months
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
35 secondary outcomes
Number of Retears at 3 Months, 12 Months, and 24 Months
Time frame: 3 months, 12 months, and 24 months
Oxford Shoulder Score (OSS)
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Constant-Murley Score
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Subjective Shoulder Value (SSV)
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Medical Care
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
Time frame: 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
Time frame: 3 months, 6 months, 12 months and 24 months
Pain - Visual Analog Scale (VAS) Score
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
MRI Tendon Findings: Supraspinatus Sugaya Score
Time frame: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Sugaya Score
Time frame: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Supraspinatus Goutallier Classification
Time frame: 3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Goutallier Classification
Time frame: 3 months, 6 months, 12 months and 24 months
Total Tendon Thickness
Time frame: 3 months, 6 months, 12 months and 24 months
Total Tendon Length
Time frame: 3 months, 6 months, 12 months and 24 months
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
Time frame: Day 0, 3 months and 6 months
Size of Retear: Anteroposterior (AP) Length
Time frame: Day 0, 3 months and 6 months
Size of Retear: Mediolateral (ML) Length
Time frame: Day 0, 3 months and 6 months
Shape of Retear: Operative Visit
Time frame: Day 0
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
Time frame: 3 months, 6 months, 12 months and 24 months
Return to Work Questionnaire
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
Return to Work Questionnaire: Reason for Not Getting Back to Work
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Reason Couldn't Return to Activities
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Time Off
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Duration Away From Work (Days)
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Duration of Opioid Use
Time frame: Following surgery, up to 14 days
Opioid Use for More Than 5 Days Post-Surgery
Time frame: Following surgery, up to 14 days
Total Operative Time
Time frame: Intraoperative
Sling Type
Time frame: up to 3 months
Mobilization Time in Sling
Time frame: up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Chris Peach, MBBS MD FRCS (Tr&Orth) principal investigator
Manchester University NHS Foundation Trust
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair and Arthroscopic rotator cuff repair for revision surgery in people with Rotator Cuff Injuries, run by Smith & Nephew, Inc. at 30 sites in 8 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 5 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, United Kingdom, France, Canada, Australia and 3 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retear Rate at 6 Months (time frame: 6 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 23 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.