Partial rotator cuff tear repair trial

Not Applicable

• Conditions: Subacromial pain and suspected partial-thickness rotator cuff tear; Injury, Occupational Diseases, Poisoning; Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder

• Registration Number: ISRCTN60983694
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Preprint results in https://doi.org/10.3310/nihropenres.1115211.1 (added 01/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-02
• Last Update Posted: 13 November 2023
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

1. Over 18 years of age
2. Willing and able to provide informed consent
3. MRI or USS suggesting a Partial Thickness Tear (PTT) diagnosis is Supraspinatus
4. An understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnairesMRI or USS suggesting a PTT diagnosis in Supraspinatus
Inclusion Criteria for randomisation (confirmed in surgery)
5. PTT more than 50% tendon thickness confirmed in Supraspinatus during arthroscopy

Exclusion Criteria

1. Patient has not had 6 months of physiotherapy
2. Patient has not had at least one steroid injection
3. Steroid injection within 6 weeks of planned surgery date
4. No Partial Thickness Tear (PTT)
5. PTT less than 50% tendon thickness
6. Any full-thickness tears on imaging or at surgery
7. Inflammatory arthritis (e.g. rheumatoid)
8. Glenohumeral osteoarthritis
9. Current active malignancy of any kind
10. Tears associated with acute fractures
11. Tears associated with shoulder dislocations
12. Upper limb neurological deficit on either side
13. Unable to undergo MRI
14. Unable to complete the written follow-up questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and function measured using the Oxford Shoulder Score (OSS) at 24 months post-randomisation

Secondary Outcome Measures

Name	Time	Method
1. Pain and function measured using the Oxford Shoulder Score (OSS) at baseline, 6, 12 months, and 5 years post-randomisation<br>2. Quality of life measured using EQ-5D-5L at baseline, 6, 12, 24 months and 5 years post-randomisation<br>3. Patient use of health resources assessed using a health resource use questionnaire at 6, 12, and 24 months post-randomisation<br>4. Patient satisfaction and perception assessed using satisfaction and perception questionnaire at 6, 12, and 24 months post-randomisation<br>5. Progression to full-thickness cuff tears assessed through MRI imaging at 24 months post-randomisation<br>6. Readmission for further surgery and associated costs assessed by routinely collected observational hospital data (HES) at 5 years post-randomisation