Understanding quality of life after rotator cuff surgery
Dynamic Changes of Functional Outcome and Generic Quality of Life After Arthroscopic Rotator Cuff Repair: a Longitudinal Study.
Chang Gung Memorial Hospital · NCT06120998
This study looks at how rotator cuff surgery affects the quality of life and shoulder function in 200 patients over time to see what helps them recover better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Kaohsiung) |
| Trial ID | NCT06120998 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the postoperative quality of life and shoulder function trajectory in patients with rotator cuff tears. It will involve 200 patients who have undergone arthroscopic rotator cuff repair, with data collected through various patient-reported outcome measures at multiple time points post-surgery. The study will utilize MRI to evaluate healing at six months and employ statistical analyses to identify factors influencing recovery and quality of life. The focus is on understanding the psychological and social impacts of surgery, which are often overlooked in clinical assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with a rotator cuff tear who are scheduled for surgical intervention and can provide informed consent.
Not a fit: Patients with severe shoulder arthritis or those with contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving postoperative care and enhancing the quality of life for patients with rotator cuff tears.
How similar studies have performed: While there is limited research specifically on postoperative quality of life in rotator cuff repair, similar studies in orthopedic surgery have shown the importance of patient-reported outcomes.
Eligibility criteria
Show full inclusion / exclusion 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: 1. Acromioclavicular arthritis requiring distal clavicular resection. 2. Severe glenohumeral arthritis (Hamada classification grade 3 or higher). 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.
Where this trial is running
Kaohsiung
- Po-Cheng Chen — Kaohsiung, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Po-Cheng Chen, M.D., M.P.H. — Chang Gung Memorial Hospital
- Study coordinator: Po-Cheng Chen, M.D., M.P.H.
- Email: b9302081@cgmh.org.tw
- Phone: 0975-368-964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tear, rotator cuff tears, quality of life, ultrasound, MRI