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Active, Not Recruiting

NCT Number: NCT03913611

Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rotator Cuff Tear or Rupture, Not Specified as Traumatic Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University Foundation NHS Trust

Manchester, M23 9LT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerated rehabilitation protocol

Other

Patients in this group will undergo an accelerated rehabilitation protocol, without movement restrictions. Movement restriction will instead be governed by patient comfort.

Traditional rehabilitation protocol

Other

Patients in this group will undergo a traditional rehabilitation protocol, with movement restrictions and sling use for 6 weeks following surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: S-START

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2019
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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