REGENETEN™ Bioinductive Implant System in Full-thickness Tears

NCT ID: NCT04450342

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2023-10-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARCR augmented with REGENETEN™ Bioinductive Implant

During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.

Group Type: EXPERIMENTAL

Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation

Intervention Type: DEVICE

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.

ARCR alone

The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing

Group Type: SHAM_COMPARATOR

Arthroscopic rotator cuff repair

Intervention Type: PROCEDURE

The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.

Revision group

Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN

Group Type: OTHER

Arthroscopic rotator cuff repair for revision surgery

Intervention Type: DEVICE

The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.

Interventions

Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation

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.

Intervention Type: DEVICE

Arthroscopic rotator cuff repair

The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.

Intervention Type: PROCEDURE

Arthroscopic rotator cuff repair for revision surgery

The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject requires Arthroscopic rotator cuff repair (ARCR);

2. 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;

3. Subject is > 40 years of age (no upper limit);

4. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;

5. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.

Exclusion Criteria

1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;

2. Subjects with Samilson-Prieto osteoarthritis > 2;

3. Subjects with current or prior infection of the ipsilateral shoulder;

4. Subjects with known hypersensitivity to bovine-derived materials;

5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;

6. Subjects with prior shoulder surgery (not including rotator cuff repair [revision repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE], subacromial decompression);

7. Subjects with an irreparable or partially reparable rotator cuff tear;

8. Subjects with a subscapularis tear requiring repair;

9. Subjects requiring a concomitant labral fixation procedure;

10. Subjects requiring a concomitant os acromiale fixation procedure;

11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations);

12. Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;

13. 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;

14. Subjects who are pregnant or breast feeding;

15. Subjects who are currently involved in any injury litigation or workers compensation claims;

16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study;

17. Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation

18. 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;

19. Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);

20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Peach, MBBS MD FRCS (Tr&Orth)

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust

Locations

Harbin Clinic

Rome, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Sinai Hospital

Baltimore, Maryland, United States

Syracuse Orthopedic Specialists

DeWitt, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Texas Orthopedic Specialists

Bedford, Texas, United States

Houston Methodist The Woodlands

The Woodlands, Texas, United States

Ashland Memorial Medical Center

Ashland, Wisconsin, United States

Macquarie University Hospital

Sydney, New South Wales, Australia

OrthoSport Victoria

Richmond, Victoria, Australia

Saint John Orthopaedics

Saint John, New Brunswick, Canada

McMaster University

Hamilton, Ontario, Canada

Women's College Hospital Toronto

Toronto, Ontario, Canada

Hôpital Ambroise Paré

Paris, Boulogne-Billancourt, France

Hôpital Pasteur 2

Nice, Provence-Alpes-Côte d'Azur Region, France

Clinique Saint-Jean - Montpellier

Montpellier, , France

Bichat Hospital

Paris, , France

Hôpital Privé de l'Ouest Parisien

Trappes, Île-de-France Region, France

Prince of Wales Hospital

Hong Kong, , Hong Kong

Singapore General Hospital

Singapore, , Singapore

Balgrist University Hospital

Zurich, , Switzerland

Schulthess Klinik

Zurich, , Switzerland

Royal Blackburn Hospital

Blackburn, Lancashire, United Kingdom

University Hospital of South Manchester NHS Foundation Trust

Wythenshawe, Manchester, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Royal National Orthopaedic Hospital NHS Trust

Stanmore, Middlesex, United Kingdom

Nottingham University Hospital

Nottingham, Nottinghamshire, United Kingdom

University Hospitals Coventry and Warwickshire

Coventry, Warwickshire, United Kingdom

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Southmead Hospital

Bristol, , United Kingdom

Countries

United States; Australia; Canada; France; Hong Kong; Singapore; Switzerland; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REGENETEN.2020.01

Identifier Type: -

Identifier Source: org_study_id