Rotator Cuff TearS-STARTNCT03913611
Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial
A study testing Accelerated rehabilitation protocol and Traditional rehabilitation protocol in people with Rotator Cuff Tear and Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- What is being tested?
- Accelerated rehabilitation protocol and Traditional rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University Foundation NHS Trust
Manchester, M23 9LT
About this study
Official title: 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.
Read more
Following surgery, they will be randomised to one of two groups:
- Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme.
- 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.
Read the 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.
- Being tested
- Accelerated rehabilitation protocol, Traditional rehabilitation protocol
- Keywords
- Shoulder arthroscopy, Rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated rehabilitation protocolOther
Patients in this group will undergo an accelerated rehabilitation protocol, without movement restrictions. Movement restriction will instead be governed by patient comfort.
Traditional rehabilitation protocolOther
Patients in this group will undergo a traditional rehabilitation protocol, with movement restrictions and sling use for 6 weeks following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Rehabilitation | Other | In this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks. Receives: Other: Traditional rehabilitation protocol |
| Accelerated Rehabilitation | Experimental | In this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period. Receives: Other: Accelerated rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 6 weeks, 3 months, 6 months, 12 months postoperatively.
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.
Measured: 6 weeks, 3 months, 6 months, 12 months postoperatively.
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.
Measured: 6 weeks, 3 months, 6 months, 12 months postoperatively.
Range of shoulder movement
Objective measure of shoulder movement in abduction, flexion and rotation planes.
Measured: 6 weeks, 3 months, 6 months, 12 months postoperatively.
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.
Measured: 6 weeks
Structural integrity of repair
This will be assessed by an MRI scan postoperatively to assess healing of the tear or failure of the repair.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start18 Oct 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to two groups, with balanced numbers entering each group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mrs K Rhodes, Study director, Manchester University Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913611
- Sponsor's protocol ID
- SSTART
- Acronym
- S-START
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Accelerated Rehabilitation Versus Standard Rehabilitation After Double-row Rotator Cuff Repair. Does Rehabilitation Regimen Affect Clinical Outcomes?
- ClinicalTrials.gov ID
- NCT03913611
- Acronym / sponsor ID
- S-START / SSTART
- Keywords
- Shoulder arthroscopy, Rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised to two groups, with balanced numbers entering each group.
| Arm | Type | Receives |
|---|---|---|
| Traditional Rehabilitation | Other | Other: Traditional rehabilitation protocolIn this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks. |
| Accelerated Rehabilitation | Experimental | Other: Accelerated rehabilitation protocolIn this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (7 listed)
- Other musculoskeletal disease affecting same limb
- Massive rotator cuff tear
- Subscapularis tear
- Incomplete cuff repair
- Repair under tension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated rehabilitation protocolPatients in this group will undergo an accelerated rehabilitation protocol, without movement restrictions. Movement restriction will instead be governed by patient comfort. | Other | Accelerated Rehabilitation |
| Traditional rehabilitation protocolPatients in this group will undergo a traditional rehabilitation protocol, with movement restrictions and sling use for 6 weeks following surgery. | Other | Traditional Rehabilitation |
Primary outcome
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.
6 secondary outcomes
Oxford Shoulder Score
Time frame: 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.
EQ5D
Time frame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
Range of shoulder movement
Time frame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
Postoperative pain score
Time frame: 6 weeks
Structural integrity of repair
Time frame: 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Trial website with more informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mrs K Rhodes study director
Manchester University Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated rehabilitation protocol and Traditional rehabilitation protocol in people with Rotator Cuff Tear and Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.