Genetic study of rotator cuff tears
Official title: Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN Study
Run by University of Michigan · NCT04831164 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 40 Years to 85 Years |
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 10 sites (Iowa City, Iowa and 9 other locations) |
| Status | Recruiting |
| Started | March 4, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2031 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT04831164 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with acute rotator cuff tears caused by severe trauma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with similar genetic approaches in understanding musculoskeletal conditions, making this study a promising continuation of that research.
Who can join: the full rules
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 it's running
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University of Iowa
Iowa City, Iowa, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
University of Texas Southwestern Medical Center
Dallas, Texas, 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
Show 4 more locations
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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
Study contacts
- Principal investigator: Nitin Jain, MD — University of Michigan
- Study coordinator: Nitin Jain, MD
- Email: jainnb@umich.edu
- Phone: 734-936-8178
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
-
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This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
-
Mobilization with Movement for people with rotator cuff lesions
This trial will test whether Mobilization with Movement helps reduce pain, improve shoulder function, and restore joint position sense in adults with rotator cuff lesions.
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Does age-related muscle loss change rotator cuff tear patterns?
We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.
-
Impact of neck nerve compression (cervical radiculopathy) on recovery after rotator cuff repair
This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
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This study tests whether using virtual reality can make shoulder rehabilitation more engaging and effective for people with shoulder injuries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.