Effect of Platelet-rich Fibrin on Rotator Cuff Repair (PRP-Fibrin)

Madrid Health Service

Status and phase: Completed; Phase 2

Conditions: Rotator Cuff Tears of the Shoulder

Treatments: Biological: PRF (vivostat ®) administration after rotator cuff repair; Procedure: Arthroscopic repair without platelet rich fibrin

Study type: Interventional

Funder types: Other

Identifiers

NCT01612845

PI-523

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

PRF

Experimental group

Description:

the group in which the PRF was administered

Treatment:

Biological: PRF (vivostat ®) administration after rotator cuff repair

Control

Active Comparator group

Description:

repair without PRF

Treatment:

Procedure: Arthroscopic repair without platelet rich fibrin