Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 5:25 AM
Study NCT ID:
NCT00923858
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2009-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Natural History of Asymptomatic Rotator Cuff Tears
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Asymptomatic Cuff Tears: A Model for Pain Development - Part B
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to provide information which can help us understand what happens over time to rotator cuff tears. In this study, the investigators will follow a population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish the probability that an asymptomatic rotator cuff tear, identified in the context of contralateral symptoms, will become symptomatic over time. To determine with ultrasound the probability that a rotator cuff tear will enlarge over time. To determine if symptom progression correlates with enlargement of the rotator cuff tear and/or degenerative changes on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1 year time points over a 5 year period. The study subjects will have repeat physical exam, ultrasound and radiographic examinations. A control group of normal patients will also be followed for comparison.
Detailed Description:
The specific aims of our study are:
1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
2. To determine which epidemiological factors correlate with symptomatic progression.
3. To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.
1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
2. To determine which epidemiological factors correlate with symptomatic progression.
3. To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01AR051026 | NIH | None | https://reporter.nih.gov/quic… | View |