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

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Injuries

In brief

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.

Key facts

Study ID

NCT05444465

Run by

Smith & Nephew, Inc.

People needed

234

Starts

2022-08-30

Expected to finish

2028-06-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Italy (enrolling)
• Hospital Ramón y Cajal — Madrid, Spain (enrolling)
• Hospital Fundación Jiménez Díaz — Madrid, Spain (enrolling)
• Ashford & St Peter's Hospitals NHS Foundation Trust — Chertsey, Surrey, United Kingdom (enrolling)
• Sulis Hospital — Bath, United Kingdom (enrolling)
• North Bristol NHS Trust — Bristol, United Kingdom (enrolling)
• Harbin Clinic — Rome, Georgia, United States (enrolling)
• OrthoIllinois LTD — Rockford, Illinois, United States (enrolling)
• OrthoSport Victoria — Richmond, Victoria, Australia (enrolling)
• Access Orthopaedics — Calgary, Alberta, Canada (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Research St. Joseph's — Hamilton, Ontario, Canada (enrolling)
• IRCCS Istituto Ortopedico Galeazzi, — Milan, Italy (enrolling)
• Northern Care Alliance NHS Foundation Trust — Salford, United Kingdom
• Sinai Hospital Baltimore — Baltimore, Maryland, United States
• Cleveland Clinic - Sports Health — Garfield Heights, Ohio, United States
• Texas Orthopedic Specialists — Bedford, Texas, United States
• Houston Methodist The Woodlands — The Woodlands, Texas, United States
• Memorial Medical Center — Ashland, Wisconsin, United States
• Pan Am Clinic — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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