Genetic study of rotator cuff tears
Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN Study
University of Michigan · NCT04831164
This study is testing whether certain genes can increase the risk of rotator cuff tears in people by comparing those with tears to those without.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 10 sites (Iowa City, Iowa and 9 other locations) |
| Trial ID | NCT04831164 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the genetic factors associated with rotator cuff tears by conducting a large-scale genome-wide association study (GWAS) involving 3000-6000 individuals with imaging-verified rotator cuff tears and an equal number of controls. Participants will complete structured questionnaires to assess medical history, mental health, and treatment expectations, with primary outcomes measured using the American Shoulder and Elbow Surgeons Standardized Form (ASES). The study seeks to identify common genetic variants that may increase the risk of developing rotator cuff tears and to replicate findings in an independent cohort.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 85 with a confirmed diagnosis of rotator cuff tears on MRI or those without tears serving as controls.
Not a fit: Patients with acute rotator cuff tears caused by severe trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of the genetic basis of rotator cuff tears, potentially guiding personalized treatment strategies.
How similar studies have performed: Other studies have shown success with similar genetic approaches in understanding musculoskeletal conditions, making this study a promising continuation of that research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥40 years to \< 85 years * Confirmed diagnosis of partial or full-thickness cuff tear on MRI (Cases) OR absence of rotator cuff tear on shoulder MRI (Controls) * Ability and willingness to provide informed consent * Ability to complete questionnaires in English (to maintain scientific integrity since standardized questionnaires are extensively validated in English) Exclusion Criteria: * Acute rotator cuff tear caused by a severe trauma
Where this trial is running
Iowa City, Iowa and 9 other locations
- University of Iowa — Iowa City, Iowa, United States (RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (COMPLETED)
- Boston Medical Center — Boston, Massachusetts, United States (COMPLETED)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (COMPLETED)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (NOT_YET_RECRUITING)
- Orthopedic Institute — Sioux Falls, South Dakota, United States (COMPLETED)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (COMPLETED)
- Parkland Health and Hospital System — Dallas, Texas, United States (COMPLETED)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Nitin Jain, MD — University of Michigan
- Study coordinator: Nitin Jain, MD
- Email: jainnb@umich.edu
- Phone: 734-936-8178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tears, rotator cuff, shoulder, GWAS, musculoskeletal