Rotator Cuff Clinical Trial
Official title:
A PROSPECTIVE STUDY TO EVALUATE SURGICAL OUTCOMES IN SUBJECTS WITH FULL-THICKNESS ROTATOR CUFF TEARS TREATED BY MEANS OF A DOUBLE-ROW ARTHROSCOPIC REPAIR.
Verified date | February 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | July 5, 2011 |
Est. primary completion date | July 5, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria: - Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size. - Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy Exclusion Criteria: - Previous surgical intervention to the shoulder joint understudy - Tears of the subscapularis or labral pathology requiring surgical repair - Shoulder instability either shoulder - Unable to complete functional evaluations in either shoulder |
Country | Name | City | State |
---|---|---|---|
United States | Texas Orthopedic Specialists, PA | Bedford | Texas |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The Everett Clinic | Everett | Washington |
United States | Orthopedic Specialists | Grapevine | Texas |
United States | Preferred Imaging | Grapevine | Texas |
United States | Kelsey Research Foundation | Houston | Texas |
United States | Kelsey Seybold Clinic | Houston | Texas |
United States | Kelsey-Seybold Spring Medical and Diagnostic Center | Houston | Texas |
United States | St. Luke's Episcopal Hospital | Houston | Texas |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | Yale-New Haven Hospital | New Haven | Connecticut |
United States | Hospital for Special Surgery | New York | New York |
United States | Mount Sinai Medical Center | New York | New York |
United States | Desert Valley Radiology | Phoenix | Arizona |
United States | Desert Valley Radiology | Phoenix | Arizona |
United States | Paradise Valley Hospital | Phoenix | Arizona |
United States | The Core Institute | Phoenix | Arizona |
United States | University Orthopedics | Providence | Rhode Island |
United States | University Orthopedics, Inc. | Providence | Rhode Island |
United States | University of Rochester Medical Center | Rochester | New York |
United States | University of Rochester Medical Center | Rochester | New York |
United States | University Orthopaedic Associates | Rochester | New York |
United States | University of California, San Francisco | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | Harris Methodist Southlake | Southlake | Texas |
United States | Banner Boswell Imaging Center | Sun City | Arizona |
United States | Banner Boswell Medical Center | Sun City | Arizona |
United States | The Core Institute | Sun City | Arizona |
United States | Banner Del E Webb Medical Center | Sun City West | Arizona |
United States | Banner Del E Webb Outpatient Diagnostics | Sun City West | Arizona |
United States | The CORE Institute-Sun City West | Sun City West | Arizona |
United States | Massachusetts General Hospital | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Secondary | 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 | ||
Secondary | Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). | 1 year | ||
Secondary | Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. | 1 year | ||
Secondary | Evaluation of the ability to define | 1 year | ||
Secondary | 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 |
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