Clinical Trials Directory

Trials / Completed

CompletedNCT01424969

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

Status
Completed
Phase
Study type
Observational
Enrollment
37 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2008-08-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2011-08-29
Last updated
2014-02-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01424969. Inclusion in this directory is not an endorsement.