Arthroscopic Treatment of Rotator Cuff Tears

NCT06961318 | Not Yet Recruiting

• 2 other identifiers: M20250255BYSYDL2024014
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Retear

  Sugaya IV \& V on MRI

  Post-op 3 months, 1 year, 2 years

Secondary Outcomes (6)

• VAS-pain

  Baseline, Post-op 3 months, 1 year, 2 years

• ASES shoulder score

  Baseline, Post-op 3 months, 1 year, 2 years

• WORC

  Baseline, Post-op 3 months, 1 year, 2 years

• EQ-5D

  Baseline, Post-op 3 months, 1 year, 2 years

• Constant-Murley shoulder score

  Baseline, Post-op 3 months, 1 year, 2 years

Other Outcomes (1)

• Complications

  Baseline, Post-op 3 months, 1 year, 2 years

Study Arms (3)

Single Row Repair

Single Row Repair

Double Row Repair

Double Row Repair

M Type Repair

M Type Repair

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary arthroscopic rotator cuff repair

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Zhenxing Shao, MD

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Zhenxing Shao, MD

CONTACT

861082267610; shaozhenxing@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)