Sub-acromial spacer for tears affecting rotator cuff tendons (START:REACTS)

Not Applicable

Completed

• Conditions: Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder; Musculoskeletal Diseases

• Registration Number: ISRCTN17825590
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31815651 study design investigation (added 10/12/2019) 2020 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247380/ protocol (added 27/11/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35461618/ (added 22/04/2022) 2023 Results article in https://doi.org/10.3310/TKJY2101 (added 10/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-06
• Study Completion: 2021-12-31
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Male and female patients presenting themselves to one of the participating hospitals with a potentially irreparable rotator cuff tendon tear will be assessed for eligibility into the study.
The eligibility criteria are:
1. Rotator cuff tear deemed by the treating clinician to be technically irreparable (to be confirmed intra-operatively)
2. Intrusive symptoms (pain and loss of function) which in the opinion of the treating clinician warrants surgery
3. Non-operative management has been unsuccessful

Exclusion Criteria

1. Advanced gleno-humeral osteoarthritis on pre-operative imaging (in the opinion of the treating clinician). Advanced gleno-humeral OA may be interpreted as Kellgren Lawrence grade 3 or 4 changes on routine pre-operative radiographs(64), or the MRI equivalent if radiographs have not been taken
2. Subscapularis deficiency*, defined as a tear involving more than the superior 1cm (approximately) of the subscapularis if repaired, or any tear that is not repaired. Minor, repairable, upper border tears are common and a repairable upper-border tear is not considered a contra-indication by the manufacturer
3. The treating surgeon determines that interposition grafting or tendon transfers are indicated. Some surgeons prefer to treat younger, more active patients with operations designed to restore or replace rotator cuff function. There is no established age criterion for this, however and the decision is based on multiple factors including age, co-morbidities, occupation, level of activity, and surgeon preference
4. Pseudoparalysis, as determined by the treating clinician
5. Unrelated, symptomatic ipsilateral shoulder disorder that would interfere with strength measurement or ability to perform rehabilitation
6. Other neurological or muscular condition that would interfere with strength measurement or ability to perform rehabilitation, in the opinion of the treating clinician
7. Previous proximal humerus fracture that could influence shoulder function, as determined by the treating clinician
8. Previous entry into the present trial (i.e. other shoulder)
9. Unable to complete trial procedures
10. Age under 18
11. Unable to consent to the trial
12. Unfit for surgery as defined by the treating clinician

Study & Design

• Study Type: Interventional
• Study Design: Not specified