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

June 5, 2012 updated by: Samuel Antuna, Hospital Universitario La Paz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF
the group in which the PRF was 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
Active Comparator: Control
repair without PRF
Procedure: Arthroscopic repair without platelet rich fibrin
after the tendon is repaired, no additional procedures are performed and no PRF is administered

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
functional outcome evaluated with constant score
Time Frame: two years
two years
disability outcome evaluated with dash score
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Collaborators

spanish society of orthopedics and traumatology

Investigators

  • Study Director: Samuel A Antuña, MD PhD, H. La Paz
  • Principal Investigator: Raul Barco, MD PhD, HU La Paz
  • Principal Investigator: Jose M Martinez, MD, HU La Paz
  • Principal Investigator: Jose M sanchez, MD, HU La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimate)

June 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-523

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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