Calcium Phosphate Cement in a Rabbit Femoral Canal Model and a Canine Humeral Plug Model: A Pilot Investigation

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CALCIUM PHOSPHATE CEMENT IN A RABBIT FEMORAL CANAL MODEL AND A CANINE HUMERAL PLUG MODEL: A PILOT INVESTIGATION

B.R. Constantz, S.W. Youngt, H.Kienapfeltt, B.L. Dahlen, D.R. Sumnertt, T.M. Turnertt,R.M. Urbantt, J.O. Galantett, S.B. Goodmanttt, and S. Gunasekaran. Norian Corporation, Mountain View, CA 94043 t Stanford University, Dept. Diagnostic Radiology ttt Stanford University, Div. Orthopaedic Surgery tt Dept. of Orthopaedic Surgery, Rush - Presbyterian-St. Luke's Med.Center, Chicago, IL

Abstract:

A new cementitious calcium phosphate biomaterial, SuperBone®, was implanted in both a rabbit femoral canal model and a canine humeral plug model. New Zealand White rabbits were implanted with cement through a novel surgical approach where cement was introduced by injection. In the canine model, a uniform gap of 3 mm around a fiber metal porous implant was filled by the cement. Undecalcified light and backscattered electron histological evaluations indicate the cement is highly biocompatible and is replaced by new bone in concert with cell-mediated resorption. Unlike the acrylic bone cement positive controls, no evidence of fibrous tissue was found around the cement. Introduction:

Traditionally, orthopaedic surgeons have employed polymethylmethacrylate (PMMA) to provide immediate fixation of total joint arthroplasties in bone or to restore immediate mechanical function to large unstable bone defects (Charnley 1979, Saha and Pal 1984). Although PMMA has functioned well in the short term, cyclic mechanical stress often leads to failure at the bone-cement or cement-prostheses interface (Sih and Berman 1980). Wear pa ticles generated from the fatigue of PMMA lead to foreign body reactions which result in bone resorption (Goldring et al. 1983, Herman et al. 1989, Jasty et al. 1990). Although "uncemented" techniques such as porous ingrowth have gained widespread interest, suboptimal clinical results have often been attained due to difficulties in machining bone precisely and an inability to provide an intimate, durable method of fixation. Thin films of ceramic hydroxyapatite have been applied to femoral stem components to increase the rate of fixation of the "cementless" components by bone ongrowth, however long-term experience is lacking (Bauer et al. 1991). An alternative concept is the use of physiologically-active cement; this technique may produce prosthetic stabilization by embedding the implant in a biodegradable "cement" capable of being replaced by native bone. The

Mat. Res. Soc. Symp. Proc. Vol. 252. 'c 1992 Materials Research Society

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purpose of this study was to perform a histological evaluation of a calcium phosphate bioactive cement implanted in the rabbit femur and around a porous coated implant in a non-weight bearing canine humeral plug gap model. Materials and Methods:

The calcium phosphate cement mixes to form a hydrous paste which may be injected into the surgical site where it hardens in minutes. The presence of blood, serum, or saline solutions do not impede the hardening or mineralogic devel