Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears of the Shoulder
- Sponsor
- Hospital Universitario La Paz
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Samuel Antuna
Consultant in Shoulder and Elbow Surgery
Hospital Universitario La Paz
Eligibility Criteria
Inclusion Criteria
- •Massive rotator cuff tears affecting supraspinatus and infraspinatus
- •Failed conservative treatment for at least 6 months
- •No hematologic disorder
Exclusion Criteria
- •Rotator cuff affecting subscapularis
- •chronic infectious disease
- •clot disorders
- •low platelet count
- •history of difficulty in venous puncture
Outcomes
Primary Outcomes
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
Time Frame: one year
Secondary Outcomes
- functional outcome evaluated with constant score(two years)
- disability outcome evaluated with dash score(two years)