Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

Rotator Cuff Tear Clinical Trial

— S-START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913611
• Other study ID #: SSTART
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Manchester University NHS Foundation Trust
• Contact: Christopher Peach, MBBS MD
• Phone: +44 161 9987070
• Email: chris.peach[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear
• Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Rupture

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Manchester University Foundation NHS Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Shoulder Score	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	Oxford Shoulder Score	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.
Secondary	Shoulder Pain and Disability Index	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.
Secondary	EQ5D	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.
Secondary	Range of shoulder movement	Objective measure of shoulder movement in abduction, flexion and rotation planes.	6 weeks, 3 months, 6 months, 12 months postoperatively.
Secondary	Postoperative pain score	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
Secondary	Structural integrity of repair	This will be assessed by an MRI scan postoperatively to assess healing of the tear or failure of the repair.	6 months.

External Links

•   Trial website with more information