Clinical trial NCT06120998: Quality of Life After Arthroscopic Rotator Cuff Repair
Official title: Dynamic Changes of Functional Outcome and Generic Quality of Life After Arthroscopic Rotator Cuff Repair: a Longitudinal Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tears
quality of life
ultrasound
MRI
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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:

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.

Primary outcomes:
measure: Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
timeFrame: 1 year
Secondary outcomes:
measure: Questionnaire Survey
timeFrame: 1 year
measure: American Shoulder and Elbow Surgeons Score (ASES Score)
timeFrame: 1 year
measure: Western Ontario Rotator Cuff Index(WORC)
timeFrame: 1 year
measure: Taiwan Version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire
timeFrame: 1 year
measure: EQ-5D Quality of Life Questionnaire for Preoperative Utility Assessment
timeFrame: 1 year
Other outcomes:
measure: Magnetic Resonance Imaging (MRI) Follow-up
timeFrame: 1 year
Locations:
city: Kaohsiung
country: Taiwan
facility: Po-Cheng Chen
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Po-Cheng Chen, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris JD, Pedroza A, Jones GL; MOON (Multicenter Orthopedic Outcomes Network) Shoulder Group. Predictors of pain and function in patients with symptomatic, atraumatic full-thickness rotator cuff tears: a time-zero analysis of a prospective patient cohort enrolled in a structured physical therapy program. Am J Sports Med. 2012 Feb;40(2):359-66. doi: 10.1177/0363546511426003. Epub 2011 Nov 17.
citation: Rhee YG, Cho NS, Yoo JH. Clinical outcome and repair integrity after rotator cuff repair in patients older than 70 years versus patients younger than 70 years. Arthroscopy. 2014 May;30(5):546-54. doi: 10.1016/j.arthro.2014.02.006. Epub 2014 Mar 14.
citation: Chung SW, Park JS, Kim SH, Shin SH, Oh JH. Quality of life after arthroscopic rotator cuff repair: evaluation using SF-36 and an analysis of affecting clinical factors. Am J Sports Med. 2012 Mar;40(3):631-9. doi: 10.1177/0363546511430309. Epub 2011 Dec 21.
citation: Kolk A, Wolterbeek N, Auw Yang KG, Zijl JA, Wessel RN. Predictors of disease-specific quality of life after arthroscopic rotator cuff repair. Int Orthop. 2016 Feb;40(2):323-9. doi: 10.1007/s00264-015-2996-z. Epub 2015 Oct 27.