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

NHS Foundation Trust

Status: Enrolling

Conditions: Rotator Cuff Tear; Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Treatments: Other: Accelerated rehabilitation protocol; Other: Traditional rehabilitation protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03913611

SSTART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Traditional Rehabilitation

Other group

Description:

In this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks.

Treatment:

Other: Traditional rehabilitation protocol

Accelerated Rehabilitation

Experimental group

Description:

In this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period.

Treatment:

Other: Accelerated rehabilitation protocol