Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

NCT05444465 | Recruiting FDA Device

• 1 other identifier: REGENETEN.2021.04
• Study Type: interventional
• Target: 234
• Locations: 6 countries
• Sites: 20

Brief Summary

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Conditions

Rotator Cuff Injuries

Keywords

Rotator cuff tear; High grade partial thickness tears; REGENETEN Bioinductive Implant System

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario Rotator Cuff (WORC)

  The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).

  Change from baseline to 3 months post-intervention

Secondary Outcomes (25)

• Western Ontario Rotator Cuff (WORC)

  Pre-op, 6 weeks, 3, 6, 12 and 24 months

• Constant-Murley Score

  Pre-Op, 3, 6, 12 and 24 months

• Subjective Shoulder Value (SSV) score

  Pre-Op, 6 weeks, 3, 12 and 24 months

• EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores

  Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months

• Change in Western Ontario Rotator Cuff (WORC)

  Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months

Study Arms (2)

Isolated Bioinductive Repair

EXPERIMENTAL

Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.

Device: Isolated Bioinductive Repair

Completion and Repair

ACTIVE COMPARATOR

Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.

Procedure: Completion and Repair

Interventions

Isolated Bioinductive Repair DEVICE

Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

Also known as: REGENETEN™ Bioinductive Implant

Isolated Bioinductive Repair

Completion and Repair PROCEDURE

Standard surgical repair using the 'Completion and Repair' technique.

Completion and Repair

Eligibility Criteria

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

You may qualify if:

• The subject must provide written informed consent.
• Subject is \> eighteen (18) years of age (no upper limit).
• Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
• Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
• Subject willing and able to make all required study visits.
• Subject able to follow instructions and deemed capable of completing all study questionnaires.

You may not qualify if:

• Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
• Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
• Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
• 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, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
• Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
• Subjects with a planned surgery on the contra-lateral shoulder within the study period.
• Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
• Subjects with a full thickness rotator cuff tear.
• Subjects with a subscapularis tear requiring repair.
• Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
• Subjects requiring a concomitant os acromiale fixation procedure.
• Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
• Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (20)

Harbin Clinic

Rome, Georgia, 30165, United States

RECRUITING

OrthoIllinois LTD

Rockford, Illinois, 61107, United States

RECRUITING

Sinai Hospital Baltimore

Baltimore, Maryland, 21215, United States

WITHDRAWN

Cleveland Clinic - Sports Health

Garfield Heights, Ohio, 44125, United States

WITHDRAWN

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Texas Orthopedic Specialists

Bedford, Texas, 76021, United States

RECRUITING

Houston Methodist The Woodlands

The Woodlands, Texas, 77385, United States

WITHDRAWN

Memorial Medical Center

Ashland, Wisconsin, 54806, United States

WITHDRAWN

OrthoSport Victoria

Richmond, Victoria, 3121, Australia

RECRUITING

Access Orthopaedics

Calgary, Alberta, T2R 2G5, Canada

RECRUITING

Pan Am Clinic

Winnipeg, Manitoba, Canada

RECRUITING

Research St. Joseph's

Hamilton, Ontario, Canada

RECRUITING

IRCCS Istituto Ortopedico Galeazzi,

Milan, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy

RECRUITING

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Ashford & St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

RECRUITING

Sulis Hospital

Bath, United Kingdom

RECRUITING

North Bristol NHS Trust

Bristol, United Kingdom

RECRUITING

Northern Care Alliance NHS Foundation Trust

Salford, M6 8HD, United Kingdom

WITHDRAWN

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Laura Mills

  Smith & Nephew, Inc.

  STUDY CHAIR

Central Study Contacts

Alice Kitching

CONTACT

+44 (0) 7590001182; alice.kitching@smith-nephew.com

Mary Ozokwere

CONTACT

+1 469-560-0727; Mary.Ozokwere@smith-nephew.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 6, 2022
• Study Start: August 30, 2022
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); CA (3); AU (1); ES (2); IT (2); GB (4)