A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair
Autor: | F. Alan Barber, Joseph P. Burns, Robert Litchfield, Marc R. Labbe, Allen Deutsch |
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Rok vydání: | 2011 |
Předmět: |
Adult
Male medicine.medical_specialty Time Factors Elbow law.invention Rotator Cuff Injuries Arthroscopy Rotator Cuff Randomized controlled trial law Reference Values Tendon Injuries Suture Anchors medicine Humans Orthopedics and Sports Medicine Rotator cuff Prospective Studies Range of Motion Articular Adverse effect Aged Skin Artificial Wound Healing medicine.diagnostic_test business.industry Magnetic resonance imaging Recovery of Function Middle Aged Magnetic Resonance Imaging Surgery medicine.anatomical_structure Treatment Outcome Evaluation Studies as Topic Cuff Tears Female Shoulder Injuries Dermal matrix business Follow-Up Studies |
Zdroj: | Arthroscopy : the journal of arthroscopicrelated surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 28(1) |
ISSN: | 1526-3231 |
Popis: | 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. Gadoliniumenhanced 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. |
Databáze: | OpenAIRE |
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