Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant

NCT06857084 | Recruiting FDA Device

• 1 other identifier: REGENETEN Global Registry
• Study Type: observational
• Target: 400
• Locations: 4 countries
• Sites: 22

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.

Conditions

Rotator Cuff Injuries

Keywords

Rotator Cuff Repair; Rotator Cuff Tear; Full Thickness Tear; Partial Thickness Tear; Massive Tear; REGENETEN Bioinductive Implant

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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

  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.

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Secondary Outcomes (3)

• Retear Rate

  3 months, 6 months, 12 months, and 24 months

• Post-operative Recovery: Sling Type and Mobilization Time

  2 weeks

• Post-operative Recovery: Return to Work

  Baseline and 6 months

Study Arms (1)

Rotator cuff repair using REGENETEN

Patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant

Device: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

Interventions

Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation DEVICE

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.

Rotator cuff repair using REGENETEN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic Clinics/practices

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (22)

Melbourne Orthopaedic Group

Windsor, Victoria, 3181, Australia

RECRUITING

Schoen Klinik Lorsch

Lorsch, Rhine, 64653, Germany

RECRUITING

Schoen Klinik Dusseldorf

Düsseldorf, 40549, Germany

RECRUITING

Malteser Waldkrankenhaus Erlangen

Erlangen, 91054, Germany

RECRUITING

Sporthopaedie Heidelberg

Heidelberg, 69121, Germany

RECRUITING

St. Anna Hospital

Herne, 44649, Germany

RECRUITING

Artemed Klinikum München Süd

München, 81379, Germany

RECRUITING

OrthoMedicum Mittelhessen

Stadtallendorf, 35260, Germany

RECRUITING

Regional General Hospital F. Miulli

Acquaviva delle Fonti, Apulia, 70021, Italy

RECRUITING

Ospedale Israelitico

Roma, Italy

RECRUITING

Ospedale di Sassuolo

Sassuolo, 41049, Italy

RECRUITING

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

Spire Harpenden Hospital

Harpenden, Hertordshire, AL5 4BP, United Kingdom

RECRUITING

Spire Montefiore

Brighton, Hove, BN3 1RD, United Kingdom

RECRUITING

Burnley General Hospital

Burnley, Lancashire, BB10 2PQ, United Kingdom

RECRUITING

Burnley General Teaching Hospital

Burnley, Lancashire, BB10 2PQ, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust

Manchester, Lancashire, M23 9LT, United Kingdom

RECRUITING

Grantham and District Hospital

Grantham, Lincolnshire, NG31 8DG, United Kingdom

RECRUITING

University College London Hospitals

London, London, NW1 2BU, United Kingdom

RECRUITING

Cleveland Clinic London Hospital

London, London, SW1X 7HY, United Kingdom

RECRUITING

Sulis Hospital Bath

Bath, Somerset, BA2 8SF, United Kingdom

RECRUITING

West Hertfordshire Hospitals NHS Trust

Hertford, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Peter Lynch

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Central Study Contacts

Cat Whittall

CONTACT

+44 7841868997; catherine.whittall@smith-nephew.com

Tim Styche

CONTACT

+44 7778 321835; Tim.Styche@smith-nephew.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: October 1, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); DE (7); GB (11); AU (1)