The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair (PRP)
The objective of this study is to determine whether platelet rich plasma augmented arthroscopic rotator cuff repairs show signs of clinical and/or structural superiority when assessed at one year by shoulder functional scoring and MRI compared to literature controls. The investigators hypothesize that the study group will show a trend toward clinical and structural superiority and the investigators hope, thereby, to justify a future, prospective, randomized study.
Rotator Cuff Tear Arthropathy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair|
- The objective of this study is to determine whether PRP augmented arthroscopic rotator cuff repairs show signs of clinical and/or structural superiority to literature controls [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
We propose a prospective, pilot study, in which twenty-five consecutive patients with rotator cuff tears undergo standard arthroscopic repair augmented by a platelet rich formulation obtained using autologous blood and a commercially available preparation system. The Cascade Medical Fibrinet, Autologous Platelet System will be used. This is an FDA 510(k) approved system
The control group will be recruited retrospectively. Patients who have undergone arthroscopic repair of rotator cuff tears with similar size characteristics without PRP augmentation will be encouraged to participate by letter initially, and then by telephone invitation. The same inclusion and exclusion criteria will apply. MRI, pain, and functional scores will be collected in the same manner as the PRP group at one time point at least one year post operatively.
Rotator cuff tears commonly result in shoulder pain and upper extremity disability. The growing elderly population requires that orthopaedic surgeons increasingly face this diagnostic and treatment dilemma which accounted for an estimated 4.5 million physician visits and approximately 40,000 inpatient surgeries in 2002 7.
Arthroscopic repair of rotator cuff tears has become increasingly popular in the past 7-10 years 1. With improved arthroscopic techniques, rates of satisfactory clinical results may approach 90% 3. However, cuff re-tears following repair continue to occur at rates ranging from 11% to 94% when assessed by methods including ultrasonography, MRI arthrography, CT arthrography, and second look arthroscopy 10. Although pain, range of motion, strength, and function may still be improved from baseline if the cuff re-tears, open and arthroscopic rotator cuff repair outcomes data suggests that range of motion, strength and functional results are inferior at a minimum of two years post operatively if cuff re-tear is identifiable by ultrasonography or MRI/CT arthrography 2, 10, 11. Thus, the current trend is to develop new methods which improve the integrity of rotator cuff repair. Technical advances have improved re-tear rates to only a certain point. Preventing cuff re-tear is now felt to be a matter of improving the biology of healing. Augmentation of time-tested rotator cuff tendon repair techniques with endogenous, biologically active factors is one area being investigated.
Animal studies demonstrate that normal insertion site tendon-to-bone histo-anatomy is not achieved following tendon-to-bone repair; instead reactive scar formation predominates 4. It has been suggested that creating the biologic milieu of embryonic development would best allow the complex rotator cuff insertion site to re-form and not simply form scar 8. Although the factors required to create this milieu remain elusive, cytokines known to have a positive role in connective tissue formation have been shown to be present in rotator cuff healing and represent a potential augmentable component of the healing process 5. Platelets are a readily available source of several of these cytokines and platelet rich preparations (PRP) have therefore been used with positive clinical results to relieve chronic epicondylar tendinosis, and to augment Achilles tendon repair 6, 9. Currently there is no report in the literature of platelet rich preparation augmented rotator cuff repair.
The investigators propose a prospective, pilot study, in which twenty-five consecutive patients with rotator cuff tears undergo standard arthroscopic repair augmented by a platelet rich formulation obtained using autologous blood and a commercially available preparation system. The Cascade Medical Fibrinet, Autologous Platelet System will be used. This is an FDA 510(k) approved system.
|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|