Clinical Trials Logo

Clinical Trial Summary

This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. Null hypothesis: There is no difference in outcome between standard rehabilitation and accelerated rehabilitation after arthroscopic rotator cuff repair. Following surgery, they will be randomised to one of two groups: 1. Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme. 2. Accelerated rehabilitation with no requirement to use a sling and a structured exercise programme. The primary outcome measure will be the Oxford Shoulder Score at 6 months. We will also collect data on postoperative pain, range of shoulder movement and other subjective outcome measures. All patients will have MRI scans at 6 months postoperatively to assess the integrity of the repair, allowing comparison of failure rates between groups.


Clinical Trial Description

This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. We wish to compare clinical and radiological outcomes for patients undergoing standard rehabilitation protocols versus accelerated rehabilitation. A double-row repair will be used in this study as it has been shown in laboratory testing to be stronger and withstand significantly more cyclical loads before failure. Patients who have failed conservative treatment for their rotator cuff tears will be offered inclusion in the study. Baseline scores and measurements will be taken prior to surgery. After a successful surgical repair has been confirmed, patients will be randomised to one of two rehabilitation programmes. One programme will mandate use of a sling for 6 weeks, and another will not require use of a sling after the immediate postoperative period. All patients will be followed up for one year, at intervals of 6 weeks, 3 months, 6 months and 12 months, using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair at 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03913611
Study type Interventional
Source Manchester University NHS Foundation Trust
Contact Christopher Peach, MBBS MD
Phone +44 161 9987070
Email chris.peach@mft.nhs.uk
Status Recruiting
Phase N/A
Start date October 18, 2019
Completion date September 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT03663036 - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Suspended NCT03290196 - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics Phase 4
Active, not recruiting NCT03091075 - Oxandrolone Rotator Cuff Trial N/A
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT04566939 - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting NCT02716441 - Rotator Cuff Failure With Continuity
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Completed NCT02298023 - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) Phase 2
Completed NCT02850211 - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT01383239 - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs N/A
Completed NCT01459536 - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear N/A
Completed NCT01170312 - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation N/A
Completed NCT01204606 - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA) N/A
Terminated NCT00936559 - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair Phase 1
Completed NCT00852657 - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff N/A
Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Recruiting NCT06120998 - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT02644564 - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries N/A