Effect of Platelet-rich Fibrin on Rotator Cuff Repair

Phase 2

Completed

• Conditions: Rotator Cuff Tears of the Shoulder
• Interventions: Biological: PRF (vivostat ®) administration after rotator cuff repair; Procedure: Arthroscopic repair without platelet rich fibrin

• Registration Number: NCT01612845
• Lead Sponsor: Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2009-05
• Study Completion: 2011-06
• Status Verified: 2012-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Study First Posted: 2012-06-06
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF	PRF (vivostat ®) administration after rotator cuff repair	the group in which the PRF was administered
Control	Arthroscopic repair without platelet rich fibrin	repair without PRF

Primary Outcome Measures

Name	Time	Method
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI	one year

Secondary Outcome Measures

Name	Time	Method
functional outcome evaluated with constant score	two years
disability outcome evaluated with dash score	two years

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain