REGENETEN™ Bioinductive Implant System in Full-thickness Tears

NCT04450342 | Terminated Results DMC FDA Device

• 1 other identifier: REGENETEN.2020.01
• Study Type: interventional
• Target: 119
• Locations: 8 countries
• Sites: 30

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.

Conditions

Rotator Cuff Injuries

Keywords

Rotator cuff tendon; Full thickness tears; REGENETEN Bioinductive Implant System

Outcome Measures

Primary Outcomes (1)

• Retear Rate at 6 Months

  Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).

  6 months

Secondary Outcomes (35)

• Number of Retears at 3 Months, 12 Months, and 24 Months

  3 months, 12 months, and 24 months

• Oxford Shoulder Score (OSS)

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

• Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index

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

• Constant-Murley Score

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

• Subjective Shoulder Value (SSV)

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

Study Arms (3)

ARCR augmented with REGENETEN™ Bioinductive Implant

EXPERIMENTAL

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

Device: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation

ARCR alone

SHAM COMPARATOR

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

Procedure: Arthroscopic rotator cuff repair

Revision group

OTHER

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

Device: Arthroscopic rotator cuff repair for revision surgery

Interventions

Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation 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 augmented with REGENETEN™ Bioinductive Implant

Arthroscopic rotator cuff repair PROCEDURE

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

ARCR alone

Arthroscopic rotator cuff repair for revision surgery DEVICE

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

Revision group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject requires Arthroscopic rotator cuff repair (ARCR);
• 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;
• Subject is \> 40 years of age (no upper limit);
• Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
• Subject is willing and able to participate in required follow-up visits and is able to complete study activities.

You may not qualify if:

• Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
• Subjects with Samilson-Prieto osteoarthritis \> 2;
• Subjects with current or prior infection of the ipsilateral shoulder;
• Subjects with known hypersensitivity to bovine-derived materials;
• Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
• Subjects with prior shoulder surgery (not including rotator cuff repair \[revision repair subject group only\], biceps tenodesis/tenotomy, distal clavicle excision \[DCE\], subacromial decompression);
• Subjects with an irreparable or partially reparable rotator cuff tear;
• Subjects with a subscapularis tear requiring repair;
• Subjects requiring a concomitant labral fixation procedure;
• Subjects requiring a concomitant os acromiale fixation procedure;
• Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
• Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
• 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;
• Subjects who are pregnant or breast feeding;
• Subjects who are currently involved in any injury litigation or workers compensation claims;

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (30)

Harbin Clinic

Rome, Georgia, 30165, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Syracuse Orthopedic Specialists

DeWitt, New York, 13214, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44125, United States

Location

Texas Orthopedic Specialists

Bedford, Texas, 76021-5011, United States

Location

Houston Methodist The Woodlands

The Woodlands, Texas, 17201, United States

Location

Ashland Memorial Medical Center

Ashland, Wisconsin, 54806, United States

Location

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

Location

OrthoSport Victoria

Richmond, Victoria, 3121, Australia

Location

Saint John Orthopaedics

Saint John, New Brunswick, E2K 4X2, Canada

Location

McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

Women's College Hospital Toronto

Toronto, Ontario, M5S 1B2, Canada

Location

Hôpital Ambroise Paré

Paris, Boulogne-Billancourt, 92100, France

Location

Hôpital Pasteur 2

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

Location

Clinique Saint-Jean - Montpellier

Montpellier, 34430, France

Location

Bichat Hospital

Paris, 75018, France

Location

Hôpital Privé de l'Ouest Parisien

Trappes, Île-de-France Region, 78190, France

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Singapore General Hospital

Singapore, 169856, Singapore

Location

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Royal Blackburn Hospital

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust

Wythenshawe, Manchester, M23 9LT, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Royal National Orthopaedic Hospital NHS Trust

Stanmore, Middlesex, HA7 4LP, United Kingdom

Location

Nottingham University Hospital

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

University Hospitals Coventry and Warwickshire

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, West Midlands, B31 2AP, United Kingdom

Location

Southmead Hospital

Bristol, BS105NB, United Kingdom

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Reoperation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

The study was terminated early (Sponsor decision not related to safety) following completion the 6-month follow-up visit due to the numerous risk factors for re-tear, such as tear size and tendon medialization. The number and variability of risk factors present made it impractical to achieve a sample size necessary to statistically account for all risk factors and evaluate the influence of augmentation.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Study Officials

• Chris Peach, MBBS MD FRCS (Tr&Orth)

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: December 7, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); FR (5); HK (1); US (8); SG (1); GB (8); CA (3); CH (2)