Rotator CuffNCT06961318
Arthroscopic Treatment of Rotator Cuff Tears
An observational study of Rotator Cuff, run by Peking University Third Hospital at 1 site in China.
Trial summary
Rotator cuff tears are the primary cause of shoulder pain and functional impairment, accounting for 50% to 85% of shoulder disorders. With the acceleration of population aging in China and the increasing demand for sports brought about by the improvement of economic standards, rotator cuff tears have gradually become… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary arthroscopic rotator cuff repair
Who may be able to join
- Age 18 to 70 years
- Primary arthroscopic rotator cuff repair
- Full-thickness rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI)
- Patient has signed the informed consent form
- Patient is willing and able to participate in follow-up and evaluation procedures
Who cannot join
- Partial rotator cuff tear or irreparable massive tear
- Concurrent shoulder pathologies other than rotator cuff injury, such as frozen shoulder or shoulder instability
- History of significant trauma to the ipsilateral shoulder
- History of previous surgery on the ipsilateral shoulder
- Presence of severe systemic diseases, such as tumors or severe dysfunction of internal organs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhenxing Shao, MD, 861082267610, shaozhenxing@bjmu.edu.cn
Zhenxing Shao, MD
About this study
Rotator cuff tears are the primary cause of shoulder pain and functional impairment, accounting for 50% to 85% of shoulder disorders. With the acceleration of population aging in China and the increasing demand for sports brought about by the improvement of economic standards, rotator cuff tears have gradually become a significant social health problem that cannot be ignored. Currently, arthroscopic rotator cuff repair is the standard treatment for rotator cuff tears. However, studies have shown that the average re-tear rate after rotator cuff repair surgery is 26.6%, which can be as high as 95% for massive rotator cuff tears. Therefore, how to prevent the occurrence of re-tears after arthroscopic rotator cuff repair and improve surgical outcomes has become a hot spot for research in the field of shoulder arthroscopy. Based on previous clinical experience, our team developed an M-shaped suture technique for arthroscopic rotator cuff repair. Clinical observations have shown that the re-tear rate at one-year post-surgery is 8%, which is significantly lower than what has been reported in the literature. However, there is currently a lack of comparative studies on the efficacy of this technique versus traditional single-row and double-row suture techniques. Moreover, the current research evidence on the prognostic factors affecting rotator cuff repair surgery is conflicting, and there is still a lack of high-quality cohort studies to screen for risk factors for poor prognosis. This project aims to establish a high-quality ambispective cohort for minimally invasive arthroscopic surgery for rotator cuff tears, to compare the clinical efficacy of the M-shaped suture technique with traditional techniques, and to identify risk factors related to the prognosis after rotator cuff repair surgery. This will provide high-quality, real-world evidence to optimize the new suture technique and develop a clinical prediction model for re-tears after rotator cuff suture repair. In the long term, the project will conduct embedded intervention studies to address modifiable risk factors (including lifestyle interventions and optimization of rehabilitation protocols) and verify whether these interventions can enhance prognostic outcomes, so as to better develop a more scientific and rational management and treatment plan for patients with rotator cuff tears. We aim to address the challenge of low tendon-bone healing rates and high re-tear rates in rotator cuff repair surgery, and provide reliable, effective, and cost-effective treatment options for patients.
- Conditions
- Rotator Cuff
- Keywords
- Rotator cuff tear, arthroscopy, rotator cuff repair
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Row Repair | Single Row Repair | |
| Double Row Repair | Double Row Repair | |
| M Type Repair | M Type Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear
Sugaya IV \& V on MRI
Measured: Post-op 3 months, 1 year, 2 years
Secondary outcomes (6)
VAS-pain
VAS-pain
Measured: Baseline, Post-op 3 months, 1 year, 2 years
ASES shoulder score
ASES shoulder score
Measured: Baseline, Post-op 3 months, 1 year, 2 years
WORC
WORC
Measured: Baseline, Post-op 3 months, 1 year, 2 years
EQ-5D
EQ-5D
Measured: Baseline, Post-op 3 months, 1 year, 2 years
Constant-Murley shoulder score
Constant-Murley shoulder score
Measured: Baseline, Post-op 3 months, 1 year, 2 years
Range of Motion
Range of Motion
Measured: Baseline, Post-op 3 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start30 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator CuffStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenxing Shao, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961318
- Sponsor's protocol ID
- M20250255
- Other IDs
- BYSYDL2024014
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Treatment of Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT06961318
- Acronym / sponsor ID
- M20250255
- Conditions
- Rotator Cuff
- Keywords
- Rotator cuff tear, arthroscopy, rotator cuff repair
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 2025 (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.
Rotator cuff tears are the primary cause of shoulder pain and functional impairment, accounting for 50% to 85% of shoulder disorders. With the acceleration of population aging in China and the increasing demand for sports brought about by the improvement of economic standards, rotator cuff tears have gradually become a significant social health problem that cannot be ignored. Currently, arthroscopic rotator cuff repair is the standard treatment for rotator cuff tears. However, studies have shown that the average re-tear rate after rotator cuff repair surgery is 26.6%, which can be as high as 95% for massive rotator cuff tears. Therefore, how to prevent the occurrence of re-tears after arthroscopic rotator cuff repair and improve surgical outcomes has become a hot spot for research in the field of shoulder arthroscopy. Based on previous clinical experience, our team developed an M-shaped suture technique for arthroscopic rotator cuff repair. Clinical observations have shown that the re-tear rate at one-year post-surgery is 8%, which is significantly lower than what has been reported in the literature. However, there is currently a lack of comparative studies on the efficacy of this technique versus traditional single-row and double-row suture techniques. Moreover, the current research evidence on the prognostic factors affecting rotator cuff repair surgery is conflicting, and there is still a lack of high-quality cohort studies to screen for risk factors for poor prognosis. This project aims to establish a high-quality ambispective cohort for minimally invasive arthroscopic surgery for rotator cuff tears, to compare the clinical efficacy of the M-shaped suture technique with traditional techniques, and to identify risk factors related to the prognosis after rotator cuff repair surgery. This will provide high-quality, real-world evidence to optimize the new suture technique and develop a clinical prediction model for re-tears after rotator cuff suture repair. In the long term, the project will conduct embedded intervention studies to address modifiable risk factors (including lifestyle interventions and optimization of rehabilitation protocols) and verify whether these interventions can enhance prognostic outcomes, so as to better develop a more scientific and rational management and treatment plan for patients with rotator cuff tears. We aim to address the challenge of low tendon-bone healing rates and high re-tear rates in rotator cuff repair surgery, and provide reliable, effective, and cost-effective treatment options for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Row Repair | – | –Single Row Repair |
| Double Row Repair | – | –Double Row Repair |
| M Type Repair | – | –M Type Repair |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary arthroscopic rotator cuff repair
Key inclusion criteria (5 listed)
- Age 18 to 70 years
- Primary arthroscopic rotator cuff repair
- Full-thickness rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI)
- Patient has signed the informed consent form
- Patient is willing and able to participate in follow-up and evaluation procedures
Key exclusion criteria (5 listed)
- Partial rotator cuff tear or irreparable massive tear
- Concurrent shoulder pathologies other than rotator cuff injury, such as frozen shoulder or shoulder instability
- History of significant trauma to the ipsilateral shoulder
- History of previous surgery on the ipsilateral shoulder
- Presence of severe systemic diseases, such as tumors or severe dysfunction of internal organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retear
Time frame: Post-op 3 months, 1 year, 2 years
Sugaya IV \& V on MRI
6 secondary outcomes
VAS-pain
Time frame: Baseline, Post-op 3 months, 1 year, 2 years
ASES shoulder score
Time frame: Baseline, Post-op 3 months, 1 year, 2 years
WORC
Time frame: Baseline, Post-op 3 months, 1 year, 2 years
EQ-5D
Time frame: Baseline, Post-op 3 months, 1 year, 2 years
Constant-Murley shoulder score
Time frame: Baseline, Post-op 3 months, 1 year, 2 years
Range of Motion
Time frame: Baseline, Post-op 3 months, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Zhenxing Shao, MD study chair
Peking University Third 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, run by Peking University Third Hospital at 1 site in China.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenxing Shao, MD (861082267610, shaozhenxing@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retear (time frame: Post-op 3 months, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.