Evaluation of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: a Prospective, Multi-Center Global Registry

Recruiting

• Conditions: Rotator Cuff Injuries

• Registration Number: NCT06857084
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2025-01
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score	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	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)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative Recovery: Sling Type and Mobilization Time	2 weeks	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.
Retear Rate	3 months, 6 months, 12 months, and 24 months	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).
Post-operative Recovery: Return to Work	Baseline and 6 months	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)

Trial Locations

Locations (18)

Grantham and District Hospital; 🇬🇧 Grantham, Lincolnshire, United Kingdom

Sulis Hospital Bath; 🇬🇧 Bath, Somerset, United Kingdom

Melbourne Orthopaedic Group; 🇦🇺 Windsor, Victoria, Australia

Clinique Saint Christophe; 🇫🇷 Soissons, Aisne, France

Schoen Klinik Dusseldorf; 🇩🇪 Düsseldorf, Germany

Sporthopaedie Heidelberg; 🇩🇪 Heidelberg, Germany

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, Lancashire, United Kingdom

Spire Harpenden Hospital; 🇬🇧 Harpenden, Hertordshire, United Kingdom

Burnley General Hospital; 🇬🇧 Burnley, Lancashire, United Kingdom

Cleveland Clinic London Hospital; 🇬🇧 London, United Kingdom

Schoen Klinik Lorsch; 🇩🇪 Lorsch, Rhine, Germany

Malteser Waldkrankenhaus Erlangen; 🇩🇪 Erlangen, Germany

OrthoMedicum Mittelhessen; 🇩🇪 Stadtallendorf, Germany

Regional General Hospital F. Miulli; 🇮🇹 Acquaviva delle Fonti, Apulia, Italy

Spire Montefiore; 🇬🇧 Brighton, Hove, United Kingdom

Burnley General Teaching Hospital; 🇬🇧 Burnley, Lancashire, United Kingdom

St. Anna Hospital; 🇩🇪 Herne, Germany

University College London Hospitals; 🇬🇧 London, United Kingdom