Shoulder Surgery Traditional vs Accelerated Rehabilitation Trial

NCT03913611 | Active Not Recruiting DMC

• 1 other identifier: SSTART
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme.
2. 2.Accelerated rehabilitation with no requirement to use a sling and a structured exercise programme.

Conditions

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

Keywords

Shoulder arthroscopy; Rotator cuff repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Oxford Shoulder Score

  6 weeks, 3 months, 6 months, 12 months postoperatively.

• Shoulder Pain and Disability Index

  6 weeks, 3 months, 6 months, 12 months postoperatively.

• EQ5D

  6 weeks, 3 months, 6 months, 12 months postoperatively.

• Range of shoulder movement

  6 weeks, 3 months, 6 months, 12 months postoperatively.

• Postoperative pain score

  6 weeks

Study Arms (2)

Traditional Rehabilitation

OTHER

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

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.

Other: Accelerated rehabilitation protocol

Interventions

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.

Accelerated Rehabilitation

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.

Traditional Rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University Foundation NHS Trust

Manchester, M23 9LT, United Kingdom

Location

Related Links

• Trial website with more information

MeSH Terms

Conditions

Rotator Cuff Injuries; Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Mrs K Rhodes

  Manchester University Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: October 18, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)