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NCT04831164 · ClinicalTrials.gov registry record

Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN Study

A clinical trial of Rotator Cuff Tears, sponsored by University of Michigan.

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: 3,500
Enrollment target: 10
Study locations

NCT04831164: Recruiting study of Rotator Cuff Tears, sponsored by University of Michigan.

NCT04831164 is a study of Rotator Cuff Tears that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 3,500 participants, above the 1,106-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (216% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04831164, a study of Rotator Cuff Tears, is actively recruiting participants, sponsored by University of Michigan.

RECRUITING
Registry status: 3,500 participants
Enrollment target: 10
Study locations

Study Summary

Rotator cuff tear is one of the most common reasons to seek musculoskeletal care, and cuff repair is one of the fastest growing ambulatory surgery procedures. However, the etiology of cuff tears, reasons for variability treatment success, and causes of FI are poorly understood. A large-scale genome-wide association studies (GWAS) using imaging-verified rotator cuff tear cases and controls can address limitations in rigor of prior research and assess the genetic basis of FI and functional outcomes of cuff tear treatments. Primary Objective: To conduct a case-control GWAS of imaging-verified symptomatic rotator cuff tear in approximately 3000-6000 individuals and replicate findings in an independent set of 3000-6000 or more imaging-verified individuals to identify common variants in several genetic loci that increase risk for rotator cuff tears. Hypothesis: Common variants in several genetic loci increase risk for rotator cuff tears. Secondary Objectives: 1. To perform an imputed transcriptome-wide association study (TWAS) to identify and prioritize gene targets associated with rotator cuff tear by integrating GWAS summary statistics and gene-expression weights from muscle and adipose tissue available in the GTEx project. Hypothesis: Genetically predicted gene expression of multiple genes in muscle and adipose tissue are associated with rotator cuff tear. 2. To identify if single nucleotide polymorphisms (SNPs) associated with rotator cuff tear and their genetic risk score (GRS) predict improved pain and function as measured by American Shoulder and Elbow Surgeons Standardized Form (ASES) and other outcome measures. Hypothesis: Select SNPs and GRS predict ASES outcome. 3. To identify genetic variants associated with Fatty Infiltration (FI) in patients with cuff tears in a two stage GWAS of imaged rotator cuffs and to prioritize gene targets through an imputed-TWAS in muscle and adipose tissue. Hypothesis: Multiple genetic variants are associated with FI a

Primary Outcome

Discovery of targeted variants in MRI verified cases and controls

Conditions Studied

Rotator Cuff Tears

Interventions

OTHER NA (not an interventional study)

Study Locations (10)

Massachusetts

Brigham and Women's Hospital - Boston
Boston Medical Center - Boston
Beth Israel Deaconess Medical Center - Boston

Texas

Parkland Health and Hospital System - Dallas
University of Texas Southwestern Medical Center - Dallas

Iowa

University of Iowa - Iowa City

Michigan

University of Michigan - Ann Arbor

Ohio

Ohio State University - Columbus

South Dakota

Orthopedic Institute - Sioux Falls

Tennessee

Vanderbilt University Medical Center - Nashville

Trial Details

Field	Value
Enrollment Target	3,500 participants
Start Date	2021-03-04
Est. Completion	2031-12-31

University of Michigan

1,327 total trials

What NCT04831164 shows while recruiting

NCT04831164 is an observational study that tracks outcomes without assigning an intervention. Its 3,500 participants enrollment target places it among the larger protocols in the corpus, above the 1,106-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (216% higher).

The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which NA (not an interventional study) is the first listed.

NCT04831164 lists 10 locations in 7 states (Massachusetts, Texas, Iowa).

Frequently Asked Questions

What is clinical trial NCT04831164 about?

NCT04831164 is a clinical study titled "Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN Study". Rotator cuff tear is one of the most common reasons to seek musculoskeletal care, and cuff repair is one of the fastest growing ambulatory surgery procedures. However, the etiology of cuff tears, reasons for variability treatment success, and causes of FI are poorly understood. A large-scale genome-...

What is the current status of trial NCT04831164?

This trial is currently recruiting. The enrollment target is 3,500 participants. The study started on 2021-03-04. Estimated completion is 2031-12-31.

What conditions does trial NCT04831164 study?

This clinical trial studies the following conditions: Rotator Cuff Tears.

What interventions are being tested in trial NCT04831164?

The interventions under investigation include: NA (not an interventional study) (OTHER).

Who is sponsoring clinical trial NCT04831164?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04831164 being conducted?

This trial has 10 study locations across Iowa, Massachusetts, Michigan, Ohio, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Rotator Cuff Tears

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04831164's enrollment target sits among peer trials

3,500 2nd of 20 the highest of 20 other Rotator Cuff Tears trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Rotator Cuff Tears trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04831164, the US trial registry maintained by the National Library of Medicine. NCT04831164 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.