Clinical trial NCT03913611: Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial
Official title: A Randomised Controlled Trial of Accelerated Rehabilitation Versus Standard Rehabilitation After Double-row Rotator Cuff Repair. Does Rehabilitation Regimen Affect Clinical Outcomes?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Keywords: Shoulder arthroscopy
Rotator cuff repair
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2019-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised to two groups, with balanced numbers entering each group.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxford Shoulder Score
timeFrame: 3 months
Secondary outcomes:
measure: Oxford Shoulder Score
timeFrame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
measure: Shoulder Pain and Disability Index
timeFrame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
measure: EQ5D
timeFrame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
measure: Range of shoulder movement
timeFrame: 6 weeks, 3 months, 6 months, 12 months postoperatively.
measure: Postoperative pain score
timeFrame: 6 weeks
measure: Structural integrity of repair
timeFrame: 6 months.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University Foundation NHS Trust
Study officials:
affiliation: Manchester University Foundation Trust
name: Mrs K Rhodes
role: STUDY_DIRECTOR
References: