What is the REGENETEN™ Bioinductive Implant studying for rotator cuff injuries?

This trial is studying whether the REGENETEN™ Bioinductive Implant helps patients with high-grade partial-thickness rotator cuff tears recover function faster compared to the standard surgical repair method called Completion and Repair. The research aims to understand which surgical approach may allow a quicker return to daily activities. The study is sponsored by Smith & Nephew, Inc.

Who may be eligible for this rotator cuff injury clinical trial?

Adults aged 18 years or older with a high-grade partial thickness tear of the supraspinatus tendon, who have tried at least 3 months of conservative treatment without success, may be eligible. Both men and women can participate. People with prior shoulder surgery or infections in the affected shoulder are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this rotator cuff injury clinical trial?

Study-related care, including the surgical procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05444465

Study of REGENETEN Bioinductive Implant Versus Standard Repair for High Grade Partial-Thickness Rotator Cuff Tears Evaluating Safety and Recovery Outcomes in Surgical Treatment

Led by Smith & Nephew, Inc. · Updated on 2026-08-05

234

Participants Needed

Research Sites

97 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the REGENETEN Bioinductive Implant system in patients with high-grade partial-thickness tears of the rotator cuff. The study compares this implant to the standard surgical technique called Completion and Repair to see which approach allows patients to return to their everyday activities faster. The study focuses on functional recovery at 3 months post-treatment and is designed as a randomized controlled trial. Participants receive either the Isolated Bioinductive Repair using the REGENETEN implant or the standard Completion and Repair surgical procedure. These interventions are compared in a parallel-group design. The main study period includes follow-up assessments up to 24 months after surgery, with evaluations at multiple time points that measure shoulder function, pain, tendon healing via MRI, and patient satisfaction. During the study, participants will undergo regular assessments including clinical scores such as the Western Ontario Rotator Cuff WORC index, Constant-Murley Score, and Subjective Shoulder Value SSV. Imaging with MRI will evaluate tendon repair status at 12 months. Researchers will also monitor pain levels, opioid use, physical therapy utilization, and time to return to work, driving, and sports. The primary outcome is the change in WORC score from baseline to 3 months post-intervention, with additional secondary outcomes tracked over 2 years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

The subject must provide written informed consent.
Subject is over 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 will not qualify if you...

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.

Research Team

Judith Horner

Mary Ozokwere

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Study of REGENETEN Bioinductive Implant Versus Standard Repair for High Grade Partial-Thickness Rotator Cuff Tears Evaluating Safety and Recovery Outcomes in Surgical Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria