Rotator Cuff TearNCT06120998
Quality of Life After Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tear, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic rotator cuff repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 201 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Changes of Functional Outcome and Generic Quality of Life After Arthroscopic Rotator Cuff Repair: a Longitudinal Study.
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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic rotator cuff repair
- Keywords
- rotator cuff tears, quality of life, ultrasound, MRI
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
- 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.
- 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.
Measured: 1 year
Secondary outcomes (5)
Questionnaire Survey
The following scales were administered to the patients before surgery and at 2 weeks, as well as at 3, 6, 9, and 12 months postoperatively. Owing to notable swelling and discomfort at the surgical site and joint at the 2-week postoperative mark, measurements of shoulder joint angles and strength were not advisable.
Measured: 1 year
American Shoulder and Elbow Surgeons Score (ASES Score)
The ASES Score has been validated for use in patients with shoulder arthritis, shoulder instability, rotator cuff tears, and in those who have undergone shoulder arthroplasty. The ASES questionnaire comprises sections evaluated by physicians and self-reported by patients. The questionnaire focused on joint pain, instability, and activities of daily living. It consists of 17 questions, including one for the pain score and ten for the daily living function assessment. The final pain score was computed using an independent formula, whereas the raw functional scores were multiplied by coefficients to derive the overall functional score. The pain and functional components were then combined to yield the total ASES score, with higher scores indicating better prognosis.
Measured: 1 year
Western Ontario Rotator Cuff Index(WORC)
The Western Ontario Rotator Cuff Index (WORC) questionnaire is primarily designed to aid in understanding the specific symptoms and functional limitations related to rotator cuff tendon pathology. It comprises 21 questions organized into five domains: Physical Symptoms, Leisure and Recreation, Work, Social, and Emotional. Each question was scored on a scale of 0 to 100, resulting in a total score ranging from 0 to 2100. Higher scores indicated a worse prognosis. However, for the purpose of comparison with other scales, the total score is subtracted by 2100 and then divided by 21 to convert it into a percentage. In this scenario, higher scores indicate a better prognosis.
Measured: 1 year
Taiwan Version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire
The Taiwan version of the WHOQOL-BREF consists of 28 questions, measuring overall Quality of Life (QOL), general health status, and 26 aspects of quality of life across four main domains: Physical Health (covering the original physical and independence domains), psychological (encompassing the original psychological and spiritual/religious/personal belief domains), Social Relationships, and Environment. Higher scores indicate better prognosis.
Measured: 1 year
EQ-5D Quality of Life Questionnaire for Preoperative Utility Assessment
The EQ-5D is a preference-based health-related quality of life measurement tool comprising five dimensions of self-classification items and a self-assessment scale for current health status ranging from 0 to 100. Each of the five dimensions has three different levels of options and various combinations correspond to different utility values. Higher utility values indicate better prognosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Sep 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Cheng Chen, M.D., M.P.H., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120998
- Sponsor's protocol ID
- CMRPG8L0901
- Status last verified
- Oct 2023
- First submitted
- 2 Nov 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22095706Rhee 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.
PubMed 24630958Chung 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.
PubMed 22190415Kolk 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.
PubMed 26508496
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Functional Outcome and Generic Quality of Life After Arthroscopic Rotator Cuff Repair: a Longitudinal Study.
- ClinicalTrials.gov ID
- NCT06120998
- Acronym / sponsor ID
- CMRPG8L0901
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tears, quality of life, ultrasound, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rotator cuff tears pending for arthroscopic rotator cuff repair | – | Procedure: Arthroscopic rotator cuff repairThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff repairAll 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. | Procedure or surgery | Patients with rotator cuff tears pending for arthroscopic rotator cuff repair |
Primary outcome
Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
Time frame: 1 year
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.
5 secondary outcomes
Questionnaire Survey
Time frame: 1 year
American Shoulder and Elbow Surgeons Score (ASES Score)
Time frame: 1 year
Western Ontario Rotator Cuff Index(WORC)
Time frame: 1 year
Taiwan Version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire
Time frame: 1 year
EQ-5D Quality of Life Questionnaire for Preoperative Utility Assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 22095706Harris 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.
- Results publication: PubMed 24630958Rhee 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.
- Results publication: PubMed 22190415Chung 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.
- Results publication: PubMed 26508496Kolk 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Tear
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Po-Cheng Chen, M.D., M.P.H. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06120998, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.