Effect of Platelet-rich Fibrin on Rotator Cuff Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial

Conditions
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Rotator Cuff Tears of the Shoulder

Intervention / Treatment
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* Procedure: Arthroscopic repair without platelet rich fibrin
* Biological: PRF (vivostat ®) administration after rotator cuff repair


Participation Criteria
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Eligibility Criteria
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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 anemia clot disorders low platelet count history of difficulty in venous puncture
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF<br>the group in which the PRF was administered | Biological: PRF (vivostat ®) administration after rotator cuff repair<br>* 7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff<br>|
| Active Comparator: Control<br>repair without PRF | Procedure: Arthroscopic repair without platelet rich fibrin<br>* after the tendon is repaired, no additional procedures are performed and no PRF is administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome evaluated with constant score |  | two years | 
| disability outcome evaluated with dash score |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff, shoulder, platelet rich plasma, fibrin