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| ID | Type | Description | Link |
|---|---|---|---|
| 1605-35413 | Other Grant/Funding Number | PCORI | |
| U34AR069201 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.
Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up
Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears
5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative | Active Comparator | surgery + post-operative physical therapy |
|
| Non-Operative | Active Comparator | non-operative physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Rotator Cuff Surgery | Procedure | Arthroscopic rotator cuff surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain & Disability Index (SPADI) | SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst. | Study participants will be followed for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) | ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best. | Study participants will be followed for 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nitin B Jain, MD,MSPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| University of California - San Francisco (UCSF) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31397866 | Derived | Jain NB, Ayers GD, Koudelkova H, Archer KR, Dickinson R, Richardson B, Derryberry M, Kuhn JE; ARC Trial Group. Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199050. doi: 10.1001/jamanetworkopen.2019.9050. |
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| Physical Therapy |
| Procedure |
Physical therapy |
|
| San Francisco |
| California |
| 94158 |
| United States |
| Western Orthopaedics | Denver | Colorado | 80218 | United States |
| University of Colorado - Denver | Denver | Colorado | 80222 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins | Baltimore | Maryland | 21218 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43202 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Orthopedic Institute | Sioux Falls | South Dakota | 57105 | United States |
| Ortho Tennessee - Knoxville Orthopedic Clinic | Knoxville | Tennessee | 37922 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Ortho Virginia | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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