Recruiting

REGENETEN™

Sponsor:

Smith & Nephew, Inc.

Code:

NCT05444465

Conditions

Rotator Cuff Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Isolated Bioinductive Repair

Completion and Repair

Study Details

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

Study ID

NCT05444465

Start date

Aug 30, 2022

Status verified date

Dec, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Subjects with neurologic conditions effecting either upper extremity.
  • Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
  • Subjects who are pregnant or breast feeding.
  • Subjects who are currently involved in any injury litigation relating to the index shoulder.
  • Subjects with current workers compensation claim.
  • Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
  • Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
  • 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.
  • Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
  • Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
  • Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
  • Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Study Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Isolated Bioinductive Repair

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

active comparator: Completion and Repair

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

Interventions

Isolated Bioinductive Repair

Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

Completion and Repair

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

Primary outcome measure

  • Change in Western Ontario Rotator Cuff (WORC) [ Time Frame: Change from baseline to 3 months post-intervention ]

Central Contacts and Locations

Central contacts

Judith Horner

+44 (0) 7834614336judith.horner@smith-nephew.com

Mary Ozokwere

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

Locations

Harbin Clinic

Recruiting

Rome, Georgia, United States, 30165

Principal Investigator:

Brandon Bushnell

OrthoIllinois LTD

Recruiting

Rockford, Illinois, United States, 61107

Principal Investigator:

Scott Trenhaile

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Albert Lin

Access Orthopaedics

Recruiting

Calgary, Alberta, Canada, T2R 2G5

Principal Investigator:

Ian Lo

Research St. Joseph's

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Moin Khan

More Information

Sponsor

Smith & Nephew, Inc.

Last update posted

Aug 5, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Smith & Nephew, Inc. on 2026-08-05.