Quality of Life After Arthroscopic Rotator Cuff Repair

NCT06120998 | Completed

• 1 other identifier: CMRPG8L0901
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff tears; quality of life; ultrasound; MRI

Outcome Measures

Primary Outcomes (1)

• Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.

  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.

  1 year

Secondary Outcomes (5)

• Questionnaire Survey

  1 year

• American Shoulder and Elbow Surgeons Score (ASES Score)

  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

Other Outcomes (1)

• Magnetic Resonance Imaging (MRI) Follow-up

  1 year

Study Arms (1)

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.

Procedure: Arthroscopic rotator cuff repair

Interventions

Arthroscopic rotator cuff repair 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.

Patients with rotator cuff tears pending for arthroscopic rotator cuff repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Po-Cheng Chen

Kaohsiung City, 833, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 22095706 RESULT

• 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.

  PMID: 24630958 RESULT

• 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.

  PMID: 22190415 RESULT

• 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.

  PMID: 26508496 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Po-Cheng Chen, M.D., M.P.H.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: September 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 27, 2026

Record last verified: 2023-10

Locations

TW (1)