None listed
Conditions
Brief summary
This study seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (current standard, control arm) versus scaffold augmentation (using the REGENETEN scaffold, experimental arm) for symptomatic partial thickness rotator cuff tears in the shoulder. Patient outcomes will be collected over a 24-month post-operative period and will include a range of subjective and functional outcomes, radiological measures and patient satisfaction. It is hypothesized that using the REGENETEN scaffold to augment/cover the symptomatic partial thickness rotator cuff tear will lead to improved early post-operative functional recovery, compared to the current standard surgical repair.
Interventions
This prospective randomized controlled trial (RCT) seeks to investigate and compare the post-operative clinical and radiological outcome of either surgical rotator cuff repair (including arthroscopic decompression and take down of the partial thickness rotator cuff tendon tear with a double row surgical repair) versus scaffold augmentation (using the REGENETEN scaffold, including arthroscopic decompression with augmentation of the partial thickness rotator cuff tear with the REGENTEN bioinductive scaffold/implant) for symptomatic partial thickness rotator cuff tears in the shoulder. Therefore, the 'intervention' is the REGENTEN bioinductive scaffold/implant. Surgery in all cases will be undertaken by a qualified shoulder orthopaedic surgeon. There is no addition training required by the surgeon, having experience already with both interventions for some time in a routine clinical setting. Based on current clinical experience, the duration of both surgical procedures is similar and will take 45-60 minutes in duration. While both surgeries are undertaken under a general anaesthetic, atients will be discharged from hospital on the day of (or day after) surgery. This does not differ based on the two surgical interventions, though is more dictated by individual patient progression, tolerance and recovery after the anaesthetic. The appropriate intervention will be ensured in all patients via internal monitoring by the research team, liaising with a specific member of the nursing team that is independent to the research study team and on-site for all surgeries).
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion Criteria • Age 35-75 years, • Duration of symptoms (DOS) >3 months, • Unsuccessful conservative treatment comprising physiotherapy and/or a corticosteroid injection, • A high grade (50% or more) partial thickness rotator cuff tear as noted on a 3-Tesla MRI scan.
Exclusion criteria
Exclusion Criteria • Revision surgery or multi-tendon tears/pathology, • Cervical pathology and/or concomitant upper limb pathology (e.g. arthritis, nerve compression), • Adhesive capsulitis, clinical shoulder instability or previous fracture, • Infection, • Pregnancy and lactation, • Professional athlete, • Worker’s compensation or compensable claim, • Substance abuse or current mental illness, • Smoker, • Known adverse reaction to bovine derived products.