NCT01424969|Completed
The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears
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Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears
Sponsor study identifier
observational
37
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)The purpose of this study was to determine the effect of platelet-rich fibrin matrix (PRFM) augmentation to at-risk arthroscopic rotator cuff repairs on healing rates and functional outcome scores. The investigators performed an observational cohort study in which a consecutive series of patients with rotator cuff tears at risk for retear was prospectively evaluated after arthroscopic repair augmented with PRFM. Clinical and magnetic resonance imaging (MRI) outcomes of the PRFM-augmented repairs were compared with historical controls with similar at-risk tears without PRFM augmentation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 22, 2011
Actual (reported)August 29, 2011
Actual (reported)May 2012
Actual (reported)May 2012
Actual (reported)Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage. Shoulder pain scores, functional scores, and MRI data will be obtained pre-operatively and compared to the same data collected 1 year post-operatively.
1 year
Patients were selected prospectively for the study based on a 3-part algorithm used to identify rotator cuff tears at risk for retear. A total algorithm score of 3 or greater was required for enrollment in the study.
The control group were recruited retrospectively. Patients who have undergone arthroscopic repair of rotator cuff tears with similar size characteristics without PRFM augmentation will be encouraged to participate by letter initially, and then by telephone invitation. The same inclusion and exclusion criteria applied. MRI, pain, and functional scores will be collected in the same manner as the PRFM group at one time point at least one year post operatively.
Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage that meet the inclusion/exclusion criteria were asked to participate.
University of Utah Orthopedics Center
Salt Lake City, Utah, 84108, United States
Robert Burks, MD
University of Utah Orthopedics Center
37 participants (actual enrollment reported by the registry).
First Submitted
August 22, 2011
First Posted
August 29, 2011
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Massive Rotator Cuff Tear Reconstruction
Contact the study team to confirm eligibility.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
February 14, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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