NCT03913611

Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

A Randomised Controlled Trial of Accelerated Rehabilitation Versus Standard Rehabilitation After Double-row Rotator Cuff Repair. Does Rehabilitation Regimen Affect Clinical Outcomes?

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rotator Cuff Tear
• Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Interventions

Type	Name	Description
OTHER	Accelerated rehabilitation protocol	Patients in this group will undergo an accelerated rehabilitation protocol, without movement restrictions. Movement restriction will instead be governed by patient comfort.
OTHER	Traditional rehabilitation protocol	Patients in this group will undergo a traditional rehabilitation protocol, with movement restrictions and sling use for 6 weeks following surgery.

Timeline

• Start date: 2019-10-18
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-04-12
• Last updated: 2026-02-09

Locations

1 site across 1 country: United Kingdom