Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomised to two groups, with balanced numbers entering each group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The therapist assessing patients' range of movement and the radiologist assessing integrity of the repair will be blinded to the arm of the trial that the patient entered.

Study Groups

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Traditional Rehabilitation

In this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks.

Group Type OTHER

Traditional rehabilitation protocol

Intervention Type OTHER

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

Accelerated Rehabilitation

In this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period.

Group Type EXPERIMENTAL

Accelerated rehabilitation protocol

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No