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

Official title

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)

Overview

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.

Detailed 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).

Interventions

• Device Isolated Bioinductive Repair
  Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
• Procedure Completion and Repair
  Standard surgical repair using the 'Completion and Repair' technique.

Primary outcome measures

• Change in Western Ontario Rotator Cuff (WORC) [Time frame: Change from baseline to 3 months post-intervention]

Secondary outcome measures (12)

• Western Ontario Rotator Cuff (WORC) [Time frame: Pre-op, 6 weeks, 3, 6, 12 and 24 months]
• Constant-Murley Score [Time frame: Pre-Op, 3, 6, 12 and 24 months]
• Subjective Shoulder Value (SSV) score [Time frame: Pre-Op, 6 weeks, 3, 12 and 24 months]
• EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores [Time frame: Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months]
• Change in Western Ontario Rotator Cuff (WORC) [Time frame: Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months]
• Change in Constant-Murley Score [Time frame: Change from Pre-Op to 6 weeks, 3, 12 and 24 months]
• Change in Subjective Shoulder Value (SSV) score [Time frame: Change from Pre-Op to 6 weeks, 3, 12 and 24 months]
• Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score [Time frame: Pre-Op, 3, 6, 12 and 24 months]
• Percent Achieving MCID for Western Ontario Rotator Cuff (WORC) [Time frame: Pre-op, 6 weeks, 3, 6, 12 and 24 months]
• Percent Achieving MCID for Subjective Shoulder Value (SSV) score [Time frame: Pre-Op, 6 weeks, 3, 12 and 24 months]
• Patient Satisfaction [Time frame: 6 weeks, 3, 6, 12 and 24 months]
• Pain, Visual analog scale (VAS) Score [Time frame: Pre-Op, 3 and 6 weeks, 3, 12 and 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 8 centers

• Harbin Clinic — Rome
• OrthoIllinois LTD — Rockford
• Sinai Hospital Baltimore — Baltimore
• Cleveland Clinic - Sports Health — Garfield Heights
• University of Pittsburgh — Pittsburgh
• Texas Orthopedic Specialists — Bedford
• Houston Methodist The Woodlands — The Woodlands
• Memorial Medical Center — Ashland

United Kingdom · 4 centers

• Ashford & St Peter's Hospitals NHS Foundation Trust — Chertsey
• Sulis Hospital — Bath
• North Bristol NHS Trust — Bristol
• Northern Care Alliance NHS Foundation Trust — Salford

Canada · 3 centers

• Access Orthopaedics — Calgary
• Pan Am Clinic — Winnipeg
• Research St. Joseph's — Hamilton

Italy · 2 centers

• IRCCS Istituto Ortopedico Galeazzi, — Milan
• Fondazione Policlinico Universitario Campus Bio-Medico — Roma

Spain · 2 centers

• Hospital Ramón y Cajal — Madrid
• Hospital Fundación Jiménez Díaz — Madrid

Australia · 1 center

• OrthoSport Victoria — Richmond

Identifiers

NCT: NCT05444465 · REGENETEN.2021.04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗