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

Smith & Nephew

Status: Enrolling

Conditions: Rotator Cuff Injuries

Treatments: Device: Isolated Bioinductive Repair; Procedure: Completion and Repair

Study type: Interventional

Funder types: Industry

Identifiers

NCT05444465

REGENETEN.2021.04

Details and patient eligibility

About

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.

Full description

The primary objective of this study is to evaluate the functional recovery of patients with high grade (>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

234 participants in 2 patient groups

Isolated Bioinductive Repair

Experimental group

Description:

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

Treatment:

Device: Isolated Bioinductive Repair

Completion and Repair

Active Comparator group

Description:

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

Treatment:

Procedure: Completion and Repair