Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 06/04/2020:
Participants will be randomly allocated to arthroscopic debridement (the standard treatment) or arthroscopic debridement with the InSpace balloon. As the inci
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 06/04/2020: The Oxford Shoulder Score (OSS) at 12 months after surgery. As participants are randomised during surgery this means 12 months after randomisation. The original study design was based around the Constant score, which is a face to face measure taken in hospital clinics. In light of the coronavirus outbreak in March 2020, the researchers, supported by the trial’s Steering and Data Monitoring Committees as well as the funders, decided to revise the primary outcome from the Constant Score to the Oxford Shoulder Score (OSS) which is a Patient Reported Outcome Measure (PROM). This will enable the continuation of the study without exposing participants to unnecessary risks during the height of the pandemic. The Oxford Shoulder Score is simple to complete and has proved to be valid and reliable in determining the outcome from shoulder surgery. _____ Previous primary outcome measure: Shoulder function measured with the Constant-Murley score collected 12 months after surgery (note that in this study, randomisation occurs at the time of surgery, so this is also 12 months after randomisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/04/2020: 1. The Oxford Shoulder Score (OSS) at baseline, three, six, and 24 months 2. Shoulder function is measured using the Constant-Murley score at baseline, 3 and 6 months and 12 months 3. Range of pain-free shoulder movement will be measured with a (12.5 in) goniometer at baseline, 3, 6 and 12 months 4. Strength of the shoulder in abduction and flexion will be measured at baseline, 3, 6 and 12 months using a supplied IsoForceControl EVO2 dynamometer (Herkules Kunstoff, Switzerland) 5. Patient reported functional outcome will also be measured using the Western Ontario Rotator Cuff Index. This is a disease specific questionnaire looking at physical symptoms, sports/recreation, work, lifestyle and emotions. This will be collected at baseline, 3, 6 and 12 months 6. Health utility will be measured using the 5Q-5D-5L. This will be collected at baseline, 3, 6 and 12 and 24 months 7. Healthcare resource – a set of questions to collect information associated with healthcare, personal and social services costs related to the interventions being compared. This will be collected at baseline, 3, 6 and 12 months 8. Patient global assessment of change (PGIC) will be measured on a 7-point scale at 3, 6 and 12 and 24 months 9. Analgesia use – this will be a set of questions to assess use of analgesia and frequency by the participant. This will be collected at 3, 6 and 12 months 10. MRI Scans 56 for participants in the MRI sub-study eight weeks and six months post-surgery) 11. Adverse events will be collected from site reports as they occur throughout the first 12 months after randomisation, and from participants in the 3, 6 and 12 month questionnaires _____ Previous secondary outcome measures: 1. Shoulder function measured using the Constant-Murley score at baseline, 3 and 6 months 2. Range of pain-free shoulder movement measured with a goniometer at baseline, 3, 6 and 12 months 3. Strength of the shoulder in abduction and flexio | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed