Quality of Life After Arthroscopic Rotator Cuff Repair

Chang Gung Medical Foundation

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Procedure: Arthroscopic rotator cuff repair

Study type: Observational

Funder types: Other

Identifiers

NCT06120998

CMRPG8L0901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

201 participants in 1 patient group

Patients with rotator cuff tears pending for arthroscopic rotator cuff repair

Description:

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.

Treatment:

Procedure: Arthroscopic rotator cuff repair