Quality of Life After Arthroscopic Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

All patients were placed in a semi-sitting position. Initially, a posterior portal was established to explore the inside of the joint, a lateral portal was created for the removal of subacromial bursa, and an additional anterior portal was created for repairing the tendons. Measurements were taken to determine the extent of rotator cuff damage, including its anterior-posterior and medial-lateral dimensions. In cases where complete repair was possible, a single-row or double-row repair technique was used depending on the degree of tendon damage. For situations where complete repair was not feasible, partial repair was performed. If the tendon could be stretched after relaxation, it was repaired to an anatomical position near the bone bed with the assistance of acellular dermal reinforcement. However, if the tendon lacked elasticity and was fully retracted upon relaxation, acellular dermis was used to bridge the tendon back to the anatomical position.

Interventions

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Arthroscopic rotator cuff repair

All patients were placed in a semi-sitting position. Initially, a posterior portal was established to explore the inside of the joint, a lateral portal was created for the removal of subacromial bursa, and an additional anterior portal was created for repairing the tendons. Measurements were taken to determine the extent of rotator cuff damage, including its anterior-posterior and medial-lateral dimensions. In cases where complete repair was possible, a single-row or double-row repair technique was used depending on the degree of tendon damage. For situations where complete repair was not feasible, partial repair was performed. If the tendon could be stretched after relaxation, it was repaired to an anatomical position near the bone bed with the assistance of acellular dermal reinforcement. However, if the tendon lacked elasticity and was fully retracted upon relaxation, acellular dermis was used to bridge the tendon back to the anatomical position.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No