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Literature (PDF) |
UNILAB SURGIBONE®
SURGICAL IMPLANT FOR NEUROSURGICAL, ORTHOPEDIC AND RECONSTRUCTIVE SURGERY Surgeons have been aware of the need for an outside source of bone for many years, but it was not until the1950's that a heterologous bone was found that was satisfactory. The development and use of grafts in humans spans a period of almost 30O years. The first recorded instance of the use of animal bone grafts in humans was recorded by Van Meekeren in 1668. It took about 150 years for autologous grafts to be commonly accepted after that and almost 150 years for homologous grafts to be used.
Dramatic changes were made. The use of calf bone was changed to mature bovine bone increasing the strength of the bone, compression tests were added tor the load-bearing bones, chemical processing was changed, sterility tests were expanded and pyro- gen testing began. A new heterologous Unilab Surgibone emerged and a new instrument for modern surgery came into existence. Since
1975, when the Canadian Government gave marketing approval for the Unilab
Surgibone, more than 15,000 operations have been performed successfully
in Canada and thousands more worldwide. These successes are attributable
to the numerous proven advantages of Unilab Surgibone over homofogous
or autologous bone. Several types of Unilab Surgibone are available: A - Hard, load-bearing bone completely free of epiphyseal car- tilage or cortical bone: - Dowels for the Cloward Cervical fusion procedure - Rectangular blocks for the Smith-Robinson procedure for cervical fusion. - Rectangular blocks for the modified Cloward procedure for lumbar disk replacement. - Various shapes and sizes for orthopedic use. B - Non-load-bearing blocks and granulated (crushed) cancellous bone free of epiphyseal cartilage and cortical bone for filling voids created by removal of cysts and tumors. The quality and uniform sizing of Unilab Surgibone eliminates the need for an operation to harvest autologous bone. Because of its hardness and availablity, Surgibone may be used in multiple level spinal implants. One, two, or three level cervical diskectomies may be performed during a single operation. Two, three or four Unilab Surgibones may be used in each level in lum- bar disk replacement. (No less than two bones should be used at each level). Successful three level lumbar disk replacements are now possible. COMPATIBILITY Since Unilab Surgibone is natural, organic bone, no foreign body reactions have been reported during various clinical and animal tests. Unilab Surgibone eliminates the ever-present threat of infection and contamination common to homologous bone banks. Also, Unilab Surgibone is not subject to the diseases of' the blood peculiar to humans, such as AIDS. COST REDUCTION The use of Unilab Surgibone reduces the operating time when a second operation to harvest autologous bone can be eliminated. Patient in-hospital stay is also generally reduced by at least one day. Reduced surgeon time, reduced operating room time and reduced in-hospital stay makes Unilab Surgibone ex- tremely cost effective. No pre-operation preparation
of the bone such as soaking, cutting or sizing is required. Meralgia,
which may persist for months, is completely eliminated and the probability
of post- operative infection is greatly reduced. The development of a unique chemical cleaning process with controlled timing and elaborately sequenced procedures produc- ed an immunological and infection free bone. Every Unilab Surgibone is subject to 100% quality control inspection after each major step in the manufacturing process. Surgibones are cut to pre-determined sizes, prepackaged, sterile and ready to use. Carefully controlled clinical studies and animal tests have shown no evidence of antigenicity. Unilab Surgibone is free of systemic or cytotoxic effect and is pyrogen free. ADAPTABILITY Cancellous Unilab Surgibone is easily vascularized and biologically compatible. During the post-operative period, the process known as "creeping substitution" takes place leading to the formation of host bone, absorption of U nilab Surgibone and fusion. (Non-fusion is rare, but maybe replaced by fibrous union). Clinical studies have shown that the time required for formation of host bone by Unilab Surgibone may be of longer duration than required by autologous or homologous bone because of its hardness and density. STRENGTH Unilab Surgibone is
sterile bovine bone, from mature animals, specially processed for grafting
procedures in neurosurgery, or- thopedic and reconstructive surgery. Unilab
Surgibone is stronger than homologous or autologous bone. All dowels and
blocks used in load-bearing areas are compression tested for hardness
when configuration permits. Load-bearing shapes and sizes which cannot
be tested due to special configuration are made from carefully selected
bones. RESULTS OF CLINICAL STUDIES INVOLVING UNILAB SURGIBONE "TRANSPLANTATION OF FRESH AND PROCESSED BOVINE BONE IN GUINEA PIGS." Gert C. Rierhmueller, MD. Division of Hemotology, Department of Medicine, New York University of Medicine, New York City, New York "In all procedures designed to detect antibodies in the blood, fixed to tissue, and of the reagenic type, the results showed that fragments of fresh bovine bone, implanted in guinea pigs induced antibody forma- tion; that powdered bovine bone induced the formation to a greater degree; that aqueous extract of bovine bone caused anti- body formation; and the Unilab Surgibone implanted as a frag- ment or powder, and an aqueous extract of Unilab Surgibone did not induce antibody formation. It was concluded that the Unilab Surgibone is Non-antigenic." "ULTRASTRUCTURAL,
MORPHOLOGICAL, IMMUNOGICAL AND ROENTGENOGRAPHICAL ASPECTS OF UNILAB SURGIBONE
TRANSPLANTS IN DOG CERVICAL LUMBAR/SPINE." COMPRESSION TEST DATA On April 9th, 1990, fifty (50)pieces - 140/190 dowels were selected at random from production batch B2390 for testing to destruction. All dowels were numbered. The test pieces were tested and then the finished dowel was crushed to destruction. Normal test procedures require that each test piece withstand at least 300 kgf. Bones not carrying that compression load are destroyed. The test pieces on all dowels are the same size, 12mm diameter x 10mm long. Finished 140/190 dowels crushed to destruction. Crush point in kilograms of force (kgf)
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The
use of heterologous grafts began in the 1950's. Calf bone was the heterologous
material. However, it was only moderately successful and used on a very
small scale. In the 1960's, Unilab acquired the original calfbone process.
