None listed
Conditions
Brief summary
This study is a prospective, single-blinded, randomised controlled trial (RCT) designed to evaluate the efficacy of the ArthroFlex dermal allograft patch augmentation in the surgical repair of medium (1-3cm), large (>2.5 cm) and massive rotator cuff tears. Participants will be randomized into two groups: standard repair (control) or repair with ArthroFlex augmentation (intervention). Outcome measures, including MRI-based structural integrity, functional scores and strength analysis, will be assessed at 6-, 12-, and 24-months. Patients and outcome assessors will be blinded to group allocation, while the surgical team performing the procedure will not be blinded due to the nature of the intervention. The primary hypothesis is that patients receiving ArthroFlex augmentation will demonstrate superior pain and functional outcomes, compared to standard repair technique.
Interventions
This study is a prospective, single-blinded, randomised controlled trial (RCT) designed to evaluate the efficacy of the ArthroFlex dermal allograft patch augmentation in the surgical repair of medium (1-3cm), large (3-5cm) or massive (>5cm) rotator cuff tears. Participants will be randomized (1:1) into two groups: standard rotator cuff repair (control) or standard rotator cuff repair with ArthroFlex augmentation (intervention).
The ArthroFlex dermal allograft patch is a biohospitable, acellula
This study is a prospective, single-blinded, randomised controlled trial (RCT) designed to evaluate the efficacy of the ArthroFlex dermal allograft patch augmentation in the surgical repair of medium (1-3cm), large (3-5cm) or massive (>5cm) rotator cuff tears. Participants will be randomized (1:1) into two groups: standard rotator cuff repair (control) or standard rotator cuff repair with ArthroFlex augmentation (intervention). The ArthroFlex dermal allograft patch is a biohospitable, acellular dermal extracellular matrix intended for supplemental support and covering for soft-tissue repairs. Following the completion of the standard rotator cuff repair (i.e. the control group), patients randomised to the intervention group will then receive augmentation of their cuff repair using the Arthroflex patch, which is inserted arthroscopically via a lateral shoulder portal using the Arthrex Graft Spreader. Before insertion, the graft is prepared with luggage tag type sutures using Arthrex Fibrelink sutures. The Graft Spreader then positions the graft to cover the rotator cuff repair and associated sutures. The Arthroflex patch is then secured in place medially with 2 or 3 Arthrex Fibrestich RC anchors. Once secured medially the medial Fibrelink sutures are removed and those on the lateral corners are secured into place using two 3.5mm PushLock anchors to secure the graft laterally. The surgical time for both techniques remains similar, with the additional ArthroFlex augmentation (intervention) adding approximately 5 minutes to the overall surgical time. The administration of the Arthroflex patch in the intervention group will be confirmed at the time of surgery, and following surgery as per the official completed operation record. Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual therapist, and the same across both groups.
Sponsors
Perth Orthopaedic and Sports Medicine Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria - Adults aged 30–80 years with MRI-confirmed medium (1-3cm), large (>2.5 cm) or massive rotator cuff tears involving at least two tendons. - Suitable candidates for rotator cuff repair surgery. - Willingness to comply with follow-up visits and assessments. - Primary procedures as well as previous failed rotator cuff repairs (primary and revision repairs to be included).
Exclusion criteria
Exclusion Criteria - Irreparable rotator cuff tears (insufficient tissue for primary repair). - Goutallier classification of fatty degeneration grades 3 and 4. - Significant glenohumeral arthritis with Hamada grade 3, 4 and 5. - Large subscapularis tears, LaFosse grades 3, 4 and 5. - 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. - Patients with religious or cultural beliefs against the implantation of allograft tissue. - Patients with autoimmune disorders and/or connective/soft tissue disorders – these patients will be excluded from study participation given the confounding nature of their condition on soft tissue healing. - Smokers – to align with other studies investigating outcome after rotator cuff repair, smokers will be excluded from study participation given the known direct effect on vasculature/microvascular healing and the risk of this presenting a significant confounder on cuff healing rate. - Inability to undergo MRI for reasons that may include, though not limited to, the implantation of pacemakers and/or other medical devices for which MRI is contraindicated.
Outcome results
None listed