Barber FA, Burns JP, Deutsch A, Labbé MR, Litchfield RB, et al.
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the A.... Date of publication 2012 Jan 1;volume 28(1):8-15.
1. Arthroscopy. 2012 Jan;28(1):8-15. doi: 10.1016/j.arthro.2011.06.038. Epub 2011
Oct 5.
A prospective, randomized evaluation of acellular human dermal matrix
augmentation for arthroscopic rotator cuff repair.
Barber FA(1), Burns JP, Deutsch A, Labbé MR, Litchfield RB.
Author information:
(1)Plano Orthopedic Sports Medicine and Spine Center, Plano, Texas 75093, USA.
PURPOSE: To prospectively evaluate the safety and effectiveness of arthroscopic
acellular human dermal matrix augmentation of large rotator cuff tear repairs.
METHODS: A prospective, institutional review board-approved, multicenter series
of patients undergoing arthroscopic repair of 2-tendon rotator cuff tears
measuring greater than 3 cm were randomized by sealed envelopes opened at the
time of surgery to arthroscopic single-row rotator cuff repair with GraftJacket
acellular human dermal matrix (Wright Medical Technology, Arlington, TN)
augmentation (group 1) or without augmentation (group 2). Preoperative and
postoperative functional outcome assessments were obtained by use of the American
Shoulder and Elbow Surgeons (ASES), Constant, and University of California, Los
Angeles scales. Gadolinium-enhanced magnetic resonance imaging (MRI) evaluation
of these repairs was obtained at a mean of 14.5 months (range, 12 to 24 months).
Adverse events were recorded.
RESULTS: There were 22 patients in group 1 and 20 in group 2 with a mean age of
56 years. The mean follow-up was 24 months (range, 12 to 38 months). The ASES
score improved from 48.5 to 98.9 in group 1 and from 46.0 to 94.8 in group 2. The
scores in group 1 were statistically better than those in group 2 (P = .035). The
Constant score improved from 41.0 to 91.9 in group 1 and from 45.8 to 85.3 in
group 2. The scores in group 1 were statistically better than those in group 2 (P
= .008). The University of California, Los Angeles score improved from 13.3 to
28.2 in group 1 and from 15.9 to 28.3 in group 2 (P = .43). Gadolinium-enhanced
MRI scans showed intact cuffs in 85% of repairs in group 1 and 40% in group 2 (P
< .01). No adverse events were attributed to the presence of the matrix grafts.
CONCLUSIONS: Acellular human dermal matrix augmentation of large (>3 cm) cuff
tears involving 2 tendons showed better ASES and Constant scores and more
frequent intact cuffs as determined by gadolinium-enhanced MRI. Intact repairs
were found in 85% of the augmented group and 40% of the nonaugmented group (P <
.01). No adverse events related to the acellular human dermal matrix were
observed.
LEVEL OF EVIDENCE: Level II, lesser-quality randomized controlled trial.
Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier
Inc. All rights reserved.
DOI: 10.1016/j.arthro.2011.06.038
PMID: 21978432 [Indexed for MEDLINE]
