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| ID | Type | Description | Link |
|---|---|---|---|
| B1861001 | Other Identifier | Alias Study Number |
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This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.
Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study of the surgical outcome | Other | Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion. | 1 year | |
| Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). |
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Inclusion Criteria:
Exclusion Criteria:
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Community Sample
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Core Institute | Phoenix | Arizona | 85027 | United States | ||
| Desert Valley Radiology |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| 1 year |
| Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. | 1 year |
| Evaluation of the ability to define | 1 year |
| Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies. | 1 year |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Paradise Valley Hospital | Phoenix | Arizona | 85032 | United States |
| Desert Valley Radiology | Phoenix | Arizona | 85037 | United States |
| Banner Boswell Imaging Center | Sun City | Arizona | 85351 | United States |
| Banner Boswell Medical Center | Sun City | Arizona | 85351 | United States |
| The Core Institute | Sun City | Arizona | 85351 | United States |
| Banner Del E Webb Medical Center | Sun City West | Arizona | 85375 | United States |
| Banner Del E Webb Outpatient Diagnostics | Sun City West | Arizona | 85375 | United States |
| The CORE Institute-Sun City West | Sun City West | Arizona | 85375 | United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| University of California, San Francisco | San Francisco | California | 94120 | United States |
| University of California, San Francisco | San Francisco | California | 94143-0728 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Yale-New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Massachusetts General Hospital | Waltham | Massachusetts | 02451 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of Rochester Medical Center | Rochester | New York | 14618 | United States |
| University Orthopaedic Associates | Rochester | New York | 14618 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University Orthopedics | Providence | Rhode Island | 02905 | United States |
| University Orthopedics, Inc. | Providence | Rhode Island | 02906 | United States |
| Texas Orthopedic Specialists, PA | Bedford | Texas | 76021 | United States |
| Orthopedic Specialists | Grapevine | Texas | 76051 | United States |
| Preferred Imaging | Grapevine | Texas | 76051 | United States |
| Kelsey Research Foundation | Houston | Texas | 77005 | United States |
| Kelsey-Seybold Spring Medical and Diagnostic Center | Houston | Texas | 77014 | United States |
| Kelsey Seybold Clinic | Houston | Texas | 77025 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Harris Methodist Southlake | Southlake | Texas | 76092 | United States |
| The Everett Clinic | Everett | Washington | 98201 | 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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