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

February 5, 2026 updated by: Manchester University NHS Foundation Trust

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M23 9LT
        • Manchester University Foundation NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Traditional Rehabilitation
In this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks.
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.
Experimental: Accelerated Rehabilitation
In this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Shoulder Score
Time Frame: 3 months
A validated patient-reported outcome measure of shoulder function. This score ranges from 0-48, with higher scores representing a better outcome.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Shoulder Score
Time Frame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
A validated patient-reported outcome measure of shoulder function. This score ranges from 0-48, with higher scores representing a better outcome.
6 weeks, 3 months, 6 months, 12 months postoperatively.
Shoulder Pain and Disability Index
Time Frame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
A validated patient-reported outcome measure of shoulder function. This score is composed to two subscales. One is for pain and the other subscale is for disability. Both subscales range from 0 to 100, with lower scores representing a better outcome. The scores are averaged to provide a global score.
6 weeks, 3 months, 6 months, 12 months postoperatively.
EQ5D
Time Frame: 6 weeks, 3 months, 6 months, 12 months postoperatively.

A validated patient-reported outcome measure of general health. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This is on a range of 0 to 100, with higher scores representing a better outcome.
6 weeks, 3 months, 6 months, 12 months postoperatively.
Range of shoulder movement
Time Frame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
Objective measure of shoulder movement in abduction, flexion and rotation planes.
6 weeks, 3 months, 6 months, 12 months postoperatively.
Postoperative pain score
Time Frame: 6 weeks
Patient subjective pain scores following surgery. This is on a visual analogue scale, ranging from 0-10, with 10 representing more pain. Patients will be asked about their usual levels of pain on a weekly basis using the scale.
6 weeks
Structural integrity of repair
Time Frame: 6 months.
This will be assessed by an MRI scan postoperatively to assess healing of the tear or failure of the repair.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester University NHS Foundation Trust

Investigators

  • Study Director: Mrs K Rhodes, Manchester University Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSTART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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