Dynamic Changes of Functional Outcome and Generic Quality of Life After Arthroscopic Rotator Cuff Repair: a Longitudinal Study.
Overview
- Phase
- Not Applicable
- Intervention
- Arthroscopic rotator cuff repair
- Conditions
- Rotator Cuff Tear
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
The goal of this longitudinal study is to understand the postoperative quality of life and dynamic trajectory of shoulder function in individuals with rotator cuff tears.
Detailed Description
Rotator cuff tears (RCTs) involve rupture of shoulder tendons or muscles, leading to pain and weakness. Its prevalence increases with age and is influenced by factors such as handedness, obesity, and smoking. Although conservative treatments are common, surgery aims to restore function. However, limited research has been conducted on postoperative psychological and social changes. Patient-reported outcome (PRO) and health-related quality of life (HRQOL) assessments are gaining importance, offering comprehensive insights into patient experiences. This longitudinal study will include 200 randomized controlled trials (RCTs) of patients who undergo surgery. Demographics, physical examinations, and scales, such as ASES, WORC, WHOQOL-BREF, and EQ-5D, are collected preoperatively and at 2 weeks and 3, 6, 9, and 12 months postoperatively. MRI is used to assess postoperative healing at 6 months. Statistical analyses are performed using SAS software encompassing chi-square, t-tests, linear mixed effects models, and subgroup analyses to identify determinants of postoperative quality of life and functionality.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients were evaluated by orthopedic surgeons as having a rotator cuff tear between August 2021 and July 2022, confirmed by magnetic resonance imaging (MRI) or ultrasound. If the patients required surgery and were willing to participate in the trial, the research assistant provided informed consent.
Exclusion Criteria
- •Acromioclavicular arthritis requiring distal clavicular resection.
- •Severe glenohumeral arthritis (Hamada classification grade 3 or higher).
- •History of shoulder fracture.
- •Absolute contraindications to MRI, such as claustrophobia, pacemakers, neurostimulators, drug infusion pumps, artificial inner ear implants, and metallic implants.
Arms & Interventions
Patients with rotator cuff tears pending for arthroscopic rotator cuff repair
This is a Longitudinal Study. Patients were evaluated by orthopedic surgeons as having a rotator cuff tear, confirmed by magnetic resonance imaging (MRI) or ultrasound. If the patients required surgery and were willing to participate in the trial, the research assistant provided informed consent. The exclusion criteria were as follows. 1. Acromioclavicular arthritis requiring distal clavicular resection. 2. Severe glenohumeral arthritis (Hamada classification grade 3 or higher)15. 3. History of shoulder fracture. 4. Absolute contraindications to MRI, such as claustrophobia, pacemakers, neurostimulators, drug infusion pumps, artificial inner ear implants, and metallic implants.
Intervention: Arthroscopic rotator cuff repair
Outcomes
Primary Outcomes
Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
Time Frame: 1 year
1. Patients were seated comfortably, and a goniometer was used to measure the active range of motion (ROM) of shoulder joint angles, including internal rotation, external rotation, abduction, extension, and flexion. 2. Patients were seated comfortably and a manual hydraulic push-pull dynamometer was used to measure the strength of internal rotation, external rotation, abduction, extension, and flexion.
Secondary Outcomes
- American Shoulder and Elbow Surgeons Score (ASES Score)(1 year)
- Questionnaire Survey(1 year)
- Western Ontario Rotator Cuff Index(WORC)(1 year)
- Taiwan Version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire(1 year)
- EQ-5D Quality of Life Questionnaire for Preoperative Utility Assessment(1 year)