A clinical feasibility study to evaluate the safety and efficacy of PEOT/PBT implants for human donor site filling during mosaicplasty

被引:15
作者
Hangody L. [1 ]
Bartha L. [1 ]
Hamann D. [2 ]
Pieper J. [3 ]
Péters F. [4 ]
Riesle J. [5 ]
Vajda A. [1 ]
Novak P.K. [1 ]
Hangody L.R. [1 ]
Vasarhelyi G. [1 ]
Bodó L. [1 ]
Van Blitterswijk C. [2 ]
De Wijn J. [2 ]
Kenyeres A. [6 ]
Modis L. [6 ]
Balo E. [7 ,8 ]
机构
[1] Orthopaedic and Trauma Department, Uzsoki Hospital, 1145 Budapest
[2] Department of Tissue Regeneration, University of Twente, 7500 AE Enschede
[3] IsoTis OrthoBiologics Inc., Irvine, CA 92618
[4] IsoTis OrthoBiologics Inc., 3723 MB Bilthoven
[5] CellCoTec, 3723 MB Bilthoven
[6] Department of Anatomy, Histology and Embryology, Medical and Health Science Center, University of Debrecen
[7] Department of Traumatology and Hand Surgery, Medical and Health Science Center, University of Debrecen
[8] 4034 Debrecen
关键词
Biocompatibility; Biodegradation; Bone remodeling; Cartilage; Copolymer; In vivo;
D O I
10.1007/s00590-011-0907-6
中图分类号
学科分类号
摘要
Mosaicplasty has become a well-accepted treatment modality for articular cartilage lesions in the knee. Postoperative bleeding remains potentially concerning. This study evaluates the porous poly(ethylene oxide)terephthalate/ poly(butylene terephthalate) (PEOT/PBT) implants used for donor site filling. Empty donor sites were the controls. After 9 months, MRI, macroscopical and histological analysis were carried out. Treated defects did not cause postoperative bleeding. No adverse events or inflammatory response was observed. PEOT/PBT implants were well integrated. Empty controls occasionally showed protrusion of repair tissue at the defect margins. Surface stiffness was minimally improved compared to controls. Existing polymer fragments indicated considerable biodegradation. Histological evaluation of the filled donor sites revealed congruent fibrocartilaginous surface repair with proteoglycan-rich domains and subchondral cancellous bone formation with interspersed fibrous tissue in all implanted sites. The PEOT/PBT implants successfully reduce donor site morbidity and postoperative bleeding after mosaicplasty. Level of evidence: II. © 2011 Springer-Verlag.
引用
收藏
页码:81 / 91
页数:10
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