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

February 26, 2025 updated by: Smith & Nephew, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Windsor, Victoria, Australia, 3181
        • Not yet recruiting
        • Melbourne Orthopaedic Group
        • Contact:
        • Contact:
          • Shane Barwood
  • France
    • Aisne
      • Soissons, Aisne, France, 02200
        • Not yet recruiting
        • Clinique Saint Christophe
        • Contact:
          • Achour Deghrar
          • Phone Number: +33 323 755252
        • Contact:
          • Achour Deghrar
  • Germany
      • Düsseldorf, Germany, 40549
        • Not yet recruiting
        • Schoen Klinik Dusseldorf
        • Contact:
        • Contact:
          • Thilo Patzer
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • Malteser Waldkrankenhaus Erlangen
        • Contact:
        • Contact:
          • Thomas Tischer
      • Heidelberg, Germany, 69121
        • Not yet recruiting
        • Sporthopaedie Heidelberg
        • Contact:
        • Contact:
          • Michael Koch
      • Herne, Germany, 44649
      • Stadtallendorf, Germany, 35260
    • Rhine
      • Lorsch, Rhine, Germany, 64653
        • Not yet recruiting
        • Schoen Klinik Lorsch
        • Contact:
        • Contact:
          • Olaf Lorbach
  • Italy
    • Apulia
      • Acquaviva delle Fonti, Apulia, Italy, 70021
        • Not yet recruiting
        • Regional General Hospital F. Miulli
        • Contact:
        • Contact:
          • Raffaele Garofalo
  • United Kingdom
      • London, United Kingdom, NW1 2BU
      • London, United Kingdom, SW1X 7HY
        • Recruiting
        • Cleveland Clinic London Hospital
        • Contact:
        • Contact:
          • Philip Ahrens
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Not yet recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
        • Contact:
          • Mustafa Rashid
    • Hertordshire
      • Harpenden, Hertordshire, United Kingdom, AL5 4BP
    • Hove
      • Brighton, Hove, United Kingdom, BN3 1RD
        • Recruiting
        • Spire Montefiore
        • Contact:
        • Contact:
          • Cameron Hatrick
    • Lancashire
      • Burnley, Lancashire, United Kingdom, BB10 2PQ
        • Recruiting
        • Burnley General Hospital
        • Contact:
        • Contact:
          • Saif Hadi
      • Burnley, Lancashire, United Kingdom, BB10 2PQ
        • Recruiting
        • Burnley General Teaching Hospital
        • Contact:
        • Contact:
          • Marakam Srinivasan
      • Manchester, Lancashire, United Kingdom, M23 9LT
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
        • Contact:
          • Chris Peach
    • Lincolnshire
      • Grantham, Lincolnshire, United Kingdom, NG31 8DG
        • Recruiting
        • Grantham and District Hospital
        • Contact:
        • Contact:
          • Alun Yewlett
    • Somerset
      • Bath, Somerset, United Kingdom, BA2 8SF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Orthopaedic Clinics/practices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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).
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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.
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
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.
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Collaborators

Smith & Nephew Asia Pacific Pte

Investigators

  • Study Director: Scott Reid, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGENETEN Global Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Injuries

Clinical Trials on Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe