Using a new implant to treat partial-thickness rotator cuff tears

Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

This study is testing a new implant to see if it helps people with partial-thickness rotator cuff tears recover faster than traditional repair methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Smith & Nephew, Inc. (Industry-sponsored)
• Locations: 20 sites (Rome, Georgia and 19 other locations)
• Trial ID: NCT05444465 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the REGENETEN™ Bioinductive Implant System in promoting faster recovery for patients with high-grade partial-thickness rotator cuff tears compared to traditional repair methods. Participants will be treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR) techniques. The primary goal is to assess functional recovery at three months post-treatment. The study aims to determine if the bioinductive approach leads to quicker return to daily activities.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with isolated high-grade partial-thickness rotator cuff tears who have not improved with conservative treatment.

Not a fit: Patients with insufficient tendon tissue quality or those with certain types of osteoarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce recovery time for patients with rotator cuff injuries.

How similar studies have performed: Previous studies using bioinductive implants have shown promise, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Rome, Georgia and 19 other locations

• Harbin Clinic — Rome, Georgia, United States (Recruiting)
• OrthoIllinois LTD — Rockford, Illinois, United States (Recruiting)
• Sinai Hospital Baltimore — Baltimore, Maryland, United States (Withdrawn)
• Cleveland Clinic - Sports Health — Garfield Heights, Ohio, United States (Withdrawn)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• Texas Orthopedic Specialists — Bedford, Texas, United States (Recruiting)
• Houston Methodist The Woodlands — The Woodlands, Texas, United States (Withdrawn)
• Memorial Medical Center — Ashland, Wisconsin, United States (Withdrawn)
• OrthoSport Victoria — Richmond, Victoria, Australia (Recruiting)
• Access Orthopaedics — Calgary, Alberta, 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, Spain (Recruiting)
• Hospital Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
• Ashford & St Peter's Hospitals NHS Foundation Trust — Chertsey, Surrey, United Kingdom (Recruiting)
• Sulis Hospital — Bath, United Kingdom (Recruiting)
• North Bristol NHS Trust — Bristol, United Kingdom (Recruiting)
• Northern Care Alliance NHS Foundation Trust — Salford, United Kingdom (Withdrawn)

Study contacts

• Study coordinator: Alice Kitching

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