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REGENETEN™ Bioinductive Implant for Rotator Cuff Tears

This study is looking at two ways to treat high-grade partial-thickness (meaning it doesn't go all the way through) rotator cuff tears. You might be eligible if you are over 18 and have this type of tear in your shoulder. Researchers want to see if using the REGENETEN™ Bioinductive Implant helps people get back to their daily activities faster compared to a standard surgical repair called 'Completion and Repair'. The main goal is to measure how well your shoulder functions three months after the treatment. The study plans to enroll 234 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two different surgical treatments for rotator cuff injuries, with a planned enrollment of 234 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your functional recovery will be measured at 3 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05444465

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

Recruiting
NAAges 18+InterventionalTreatment
Smith & Nephew, Inc.
~234 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Isolated Bioinductive RepairCompletion and Repair

At a glance

Recruiting sites
13 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Western Ontario Rotator Cuff (WORC)
Measured over Change from baseline to 3 months post-intervention

Conditions

Rotator Cuff Injuries

Explore related trials

Injury of rotator cuff

Where it's being run

20 sites across 15 states
United Kingdom3
Texas2
Italy2
Spain2
Georgia1
Illinois1
Maryland1
Ohio1

Study leadership

  • Laura Mills · STUDY_CHAIR · Smith & Nephew, Inc.

Who to contact

Judith Horner
[email protected]
+44 (0) 7834614336
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Western Ontario Rotator Cuff (WORC)Change from baseline to 3 months post-intervention

    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).