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) (IMPACT)

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    156
  • sponsor
    Smith & Nephew, Inc.
Updated on 23 October 2022

Summary

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.

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).

Details
Condition Rotator Cuff Injuries
Treatment Isolated Bioinductive Repair, Completion and Repair
Clinical Study IdentifierNCT05444465
SponsorSmith & Nephew, Inc.
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

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 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 concomitant biceps tenodesis/tenotomy
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
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