NCT01612845

Effect of Platelet-rich Fibrin on Rotator Cuff Repair

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tears of the Shoulder

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic repair without platelet rich fibrin	after the tendon is repaired, no additional procedures are performed and no PRF is administered
BIOLOGICAL	PRF (vivostat ®) administration after rotator cuff repair	7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-05-01
• Completion: 2011-06-01
• First posted: 2012-06-06
• Last updated: 2012-06-06

Locations

1 site across 1 country: Spain