Clinical trial NCT06961318: Arthroscopic Treatment of Rotator Cuff Tears
Official title: Arthroscopic Treatment of Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rotator Cuff
Keywords: Rotator cuff tear
arthroscopy
rotator cuff repair
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary arthroscopic rotator cuff repair

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Retear
timeFrame: Post-op 3 months, 1 year, 2 years
Secondary outcomes:
measure: VAS-pain
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
measure: ASES shoulder score
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
measure: WORC
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
measure: EQ-5D
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
measure: Constant-Murley shoulder score
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
measure: Range of Motion
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
Other outcomes:
measure: Complications
timeFrame: Baseline, Post-op 3 months, 1 year, 2 years
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Zhenxing Shao, MD
role: STUDY_CHAIR
References: