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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults aged over 40 with a degenerate full-thickness posterosuperior rotator cuff tear undergoing arthroscopic rotator cuff repair (+/- concomitant procedures such as biceps tenotomy and subacromial decompression).

Locations
Other Locations
United Kingdom
Manchester University Foundation NHS Trust
RECRUITING
Manchester
Contact Information
Primary
Christopher Peach, MBBS MD
chris.peach@mft.nhs.uk
+44 161 9987070
Backup
Ronnie Davies, MB/BChir
ronnie.davies@mft.nhs.uk
+44 161 276 1234
Time Frame
Start Date: 2019-10-18
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 120
Treatments
Other: Traditional Rehabilitation
In this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks.
Experimental: Accelerated Rehabilitation
In this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period.
Related Therapeutic Areas
Sponsors
Leads: Manchester University NHS Foundation Trust

This content was sourced from clinicaltrials.gov