The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.
A prospective, randomized clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range, 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. In 14 patients, after the repair was completed, 6 cc. of PRF (vivostat ®) were locally applied to the repair site. In 14 patients no addition of PRF was performed. All patients underwent an arthro-MRI to evaluate the integrity of the repair and a clinical exam one year after the operation. All patients were then followed clinically at a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
after the tendon is repaired, no additional procedures are performed and no PRF is administered
7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff
Hospital Universitario La Paz
Madrid, Madrid, Spain
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
Time frame: one year
functional outcome evaluated with constant score
Time frame: two years
disability outcome evaluated with dash score
Time frame: two years
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