Document Detail


Plasma rich in growth factors in arthroscopic rotator cuff repair: a randomized, double-blind, controlled clinical trial.
MedLine Citation:
PMID:  23276410     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: The aim of this study was to determine whether addition of plasma rich in growth factors (PRGF) improves functional and structural outcomes after arthroscopic repair of full-thickness rotator cuff tears.
METHODS: The study design was independent (investigator-sponsored), randomized in parallel groups, double-blind, and controlled with a conventional surgical technique clinical trial. Sixty-nine patients with rotator cuff tears were included. Subsequently, 6 patients in whom less than 50% footprint coverage of the repair was possible were excluded. Before arthroscopic repair, patients were randomly assigned to receive PRGF at the end of arthroscopy (injected first in the repaired area and then spread over the tendon suture) or only conventional surgery. Efficacy was evaluated 1 year after surgery using functional (UCLA score) and structural (arthro-MRI) assessments.
RESULTS: The baseline UCLA scores of the PRGF (14.9; 95% confidence interval [CI]: 13.7 to 16.12) and control (13.2; 95% CI: 13.3 to 16.3) groups were similar. After surgery, both groups showed an improvement in UCLA score, without significant differences between groups (23.2; CI 95%: 20.8 to 25.7, and 23.8; 95% CI: 21.0 to 26.7, respectively). Furthermore, no significant differences were observed in satisfaction 1 year after surgery. Tendon healing evaluated with arthro-magnetic resonance imaging showed total healing in 40% of cases, partial healing in 30%, and lack of healing in 30%, again with no significant differences between groups. No adverse events were recorded.
CONCLUSIONS: The present clinical trial does not support the use of plasma rich in growth factors in the arthroscopic repair of rotator cuff tears because no differences in rotator cuff healing or improvements in function were observed in the 1-year postsurgical clinical and radiological follow-up assessments.
LEVEL OF EVIDENCE: Level I, randomized, double-blind, controlled clinical trial.
Authors:
Pedro Ruiz-Moneo; Jorge Molano-Muñoz; Estrella Prieto; Jaime Algorta
Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association     Volume:  29     ISSN:  1526-3231     ISO Abbreviation:  Arthroscopy     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-01     Completed Date:  2013-06-06     Revised Date:  2013-07-18    
Medline Journal Info:
Nlm Unique ID:  8506498     Medline TA:  Arthroscopy     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Orthopedics, Hospital Universitario de Araba, Vitoria-Gasteiz, Spain.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Arthroscopy / methods*
Double-Blind Method
Female
Humans
Intercellular Signaling Peptides and Proteins / administration & dosage,  blood,  therapeutic use*
Magnetic Resonance Imaging
Male
Middle Aged
Platelet-Rich Plasma*
Range of Motion, Articular
Rotator Cuff / injuries,  pathology,  surgery*
Severity of Illness Index
Treatment Failure
Chemical
Reg. No./Substance:
0/Intercellular Signaling Peptides and Proteins
Comments/Corrections
Comment In:
Arthroscopy. 2013 Jun;29(6):970-1   [PMID:  23726105 ]
Arthroscopy. 2013 Jun;29(6):969-70   [PMID:  23726104 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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