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

This study has been completed.
Sponsor:
Collaborator:
spanish society of orthopedics and traumatology
Information provided by (Responsible Party):
Samuel Antuna, Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01612845
First received: June 4, 2012
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Rotator Cuff Tears of the Shoulder
Procedure: Arthroscopic repair without platelet rich fibrin
Biological: PRF (vivostat ®) administration after rotator cuff repair
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial

Further study details as provided by Hospital Universitario La Paz:

Primary Outcome Measures:
  • rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • functional outcome evaluated with constant score [ Time Frame: two years ] [ Designated as safety issue: No ]
  • disability outcome evaluated with dash score [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2007
Study Completion Date: June 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01612845

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
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