Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial (S-START)

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    120
  • sponsor
    Manchester University NHS Foundation Trust
Updated on 16 June 2022
postoperative pain
rotator cuff repair
shoulder surgery

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.

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.

Details
Condition Rotator Cuff Tear, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Treatment Accelerated rehabilitation protocol, Traditional rehabilitation protocol
Clinical Study IdentifierNCT03913611
SponsorManchester University NHS Foundation Trust
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Other musculoskeletal disease affecting same limb
Massive rotator cuff tear
Subscapularis tear
Incomplete cuff repair
Repair under tension
Non-English speaker
Inability to follow postoperative instructions / restrictions
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