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

History of Changes

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

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

More Information

Publications:

Barber FA, Hrnack SA, Snyder SJ, Hapa O. Rotator cuff repair healing influenced by platelet-rich plasma construct augmentation. Arthroscopy. 2011 Aug;27(8):1029-35.

Jo CH, Kim JE, Yoon KS, Lee JH, Kang SB, Lee JH, Han HS, Rhee SH, Shin S. Does platelet-rich plasma accelerate recovery after rotator cuff repair? A prospective cohort study. Am J Sports Med. 2011 Oct;39(10):2082-90. Epub 2011 Jul 7.

Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28.

Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. Epub 2010 Dec 15.

Responsible Party:	Samuel Antuna, Consultant in Shoulder and Elbow Surgery, Hospital Universitario La Paz
ClinicalTrials.gov Identifier:	NCT01612845 History of Changes
Other Study ID Numbers:	PI-523
Study First Received:	June 4, 2012
Last Updated:	June 5, 2012
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario La Paz:

rotator cuff
shoulder
platelet rich plasma
fibrin

ClinicalTrials.gov processed this record on October 17, 2012

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