Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: Surgical treatment: Patients in group 1 will undergo an arthroscopic rotator cuff repair Conservative treatment: Conservative treatment will consist of a validated protocol for conservative RC rehabilitation (http://www.moonshoulder.com/booklets/060109PatientRehabBooklet.pdf) under the supervision of an experienced shoulder physiotherapist. Total duration of treatment: 3 months Follow‐up for all study arms Follow up at 6, 12, and 24 months Details of the randomisation process: Patients will be randomly assigned to surgical repair (Group 1) or conservative treatment (Group 2) using a computer‐generated allocation, stratified for age, gender, and affected shoulder (right or left). CONDITION: Rotator Cuff tears ; Musculoskeletal Diseases ; Rotator cuff syndrome PRIMARY OUTCOME: Pain and ability to carry out normal daily activities will be measured using the constant score at 6, 12, and 24 months. SECONDARY OUTCOME: ; 1. Shoulder function will be measured using the ASES Shoulder Score at 6, 12, and 24 months; 2. Pain will be measured using the VAS at 6, 12, and 24 months.; 3. Patient‐reported outcomes will be measured using the Oxford Shoulder Score at 6, 12, and 24 months.; 4. Rotator cuff integrity, the extent of fatty degeneration and the amount of muscle atrophy will be measured using an MRI at 6, 12 and 24 months post‐operatively.; 5. Shoulder pain and disability will be measured using the Shoulder Pain And Disability Index at 6, 12, and 24 months.; 6. Pain‐related disability will be measured using the Shoulder Disability Questionnaire at 6, 12, and 24 months.; 7. Shoulder symptoms and function will be measured using the Shoulder Rating Questionnaire at 6, 12, and 24 months.; 8. General health will be measured using the Short‐Form 36 at 6, 12, and 24 months.; INCLUSION CRITERIA: 1. Atraumatic, symptomatic, isolated full‐thickness supraspinatus tendon tear documented with MRI 2. Full passive range of motion of the shoulder.
Epistemonikos ID: b3e94ec1cadb25c48988c619afff1ed4245eda53
First added on: Aug 24, 2024