The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
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|ClinicalTrials.gov Identifier: NCT01424969|
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : February 14, 2014
|Condition or disease|
|Rotator Cuff Tear Arthropathy|
Increased age, larger tear size, and more advanced fatty degeneration of the rotator cuff musculature have been correlated with poorer healing rates after rotator cuff repair. Platelets are an endogenous source of growth factors present during rotator cuff healing.
The investigators hypothesis is that augmentation of rotator cuff repairs with platelet-rich fibrin matrix (PRFM) may improve the biology of rotator cuff healing and thus improve functional outcome scores and retear rates after repair.
Rotator cuff tears at risk for retear were prospectively identified using an algorithm; points were assigned for age (50-59 years = 1; 60-69 years = 2; .70 years = 3), anterior-to-posterior tear size (2-2.9 cm = 0; 3-3.9 cm = 1; .4 cm = 2), and fatty atrophy (Goutallier score 0-2 = 0; Goutallier score 3-4 = 1). Three points were required for enrollment. Arthroscopic rotator cuff repair was performed with the addition of PRFM. Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores were obtained. Imaging and functional outcomes were compared with historical controls meeting the same enrollment criteria.
Enrollment for the study began in September 2008 and continued until March 2010.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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.
- Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424969
|United States, Utah|
|University of Utah Orthopedics Center|
|Salt Lake city, Utah, United States, 84108|
|Principal Investigator:||Robert Burks, MD||University of Utah Orthopedics Center|