An observational study in Rotator Cuff Injuries, sponsored by Smith & Nephew, Inc.. Recruiting at 22 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Smith & Nephew, Inc. · Observational
Among 15 studies in Rotator Cuff Injuries with a site in United Kingdom — 6 open to participants now, 7 under way, none of them phase 3. Rotator Cuff Injuries · United Kingdom.
Among the 15 studies in Rotator Cuff Injuries with a site in United Kingdom, this one is one of 3 that started in 2020, is one of 5 observational ones, and was the 15th registered.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 400 is above the median of 70 across 145 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →6 of the 15 studies in Rotator Cuff Injuries with a site in United Kingdom are open now, in 8 countries. Each count lists the studies.
Of the 100 Rotator Cuff Injuries studies recruiting now, 40 (40%) set no upper age limit and 41 (41%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2020.
Median enrollment 57 across the 10 interventional studies, 250 across the 5 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
7 of 15 have an industry lead sponsor. The 10 most frequent:
Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Smith & Nephew, Inc. has 7 studies filed under Rotator Cuff Injuries — fewer than ten, so there is no comparison to draw.
3 of the studies in Rotator Cuff Injuries with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03913611Manchester University NHS Foundation TrustShoulder Surgery Traditional vs Accelerated Rehabilitation Trial | 2026-12-31 |
| NCT04975581University Hospitals, LeicesterRotator Cuff Tears Repair With or Without Dermal Patch Augmentation | 2026-12-31 |
| NCT05444465Smith & Nephew, Inc.Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears | 2027-04-15 |
Among the 15 studies in Rotator Cuff Injuries with a site in United Kingdom, from their registry updates:
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.
Orthopaedic Clinics/practices
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant
Device: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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).
Time frame: 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.
Time frame: 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)
Time frame: Baseline and 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2020 (actual). Primary completion is estimated for Dec 2029, 110 months after the start.
Of 72 observational studies under Rotator Cuff Injuries, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 165. This study's planned 110 months is above that.
How these figures are worked out, and which studies are left out of them.
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