Original submissionInstrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix, as an adjunct to autologous bone☆
Introduction
Prior investigators have reported good results with autogenous posterolateral lumbar fusion, instrumented 1, 2, 3, 4, 5, 6, 7 and noninstrumented 2, 3, 8, 9, 10, 11, 12, 13, 14, 15 for degenerative lumbar instability. However, patients with certain risk factors tend to have lower fusion rates 3, 4, 5, 6, 7, 8, 11, 13, 16, 17, 18, 19. These risk factors include patients undergoing multilevel fusion; patients with poor bone quality, such as diabetics, smokers, and patients with osteoporotic bone; as well as patients with a prior pseudarthrosis or past infection. We sought a bone graft extender or bone graft extender combination, which would augment the osteoinductive properties of autograft in difficult-to-fuse patients and in the entire patient population requiring posterolateral lumbar fusion.
Coralline hydroxyapatite is a nonimmunogenic synthetic compound manufactured from sea coral. Coral, which is primarily calcium carbonate, undergoes a patented process that changes the calcium carbonate to hydroxyapatite. The process leaves the three-dimensional microstructure of the coral intact. This microstructure of coralline hydroxyapatite mimics the microstructure of human bone. The compound assists in bone healing through osteoconduction but has no osteoinductive properties.
Pro Osteon™ 500 (Interpore Cross International, Irvine, CA) is a form of coralline hydroxyapatite with a pore size of approximately 500 microns derived from the genera goniopora. The microstructure of Pro Osteon 500 (Fig. 1) is similar to cancellous bone (Fig. 2). Several investigators have reported excellent results using coralline hydroxyapatite as a bone graft substitute and/or bone graft extender, for orthopedic 20, 21, 22, 23, 24, 25, 26, maxillofacial 27, 28, 29, orthognathic 30, 31, ophthalmologic 32, 33, 34, and spinal 35, 36, 37, 38 applications. The use of Pro Osteon for posterolateral fusion has not been reported previously in the literature, except in an animal model. In a rabbit model, Boden et al [35] demonstrated that coralline hydroxyapatite as a bone graft extender to autogenous bone had a similar fusion rate to autogenous bone alone for posterolateral lumbar fusion. A natural extension of Boden's study would be to apply the model to humans.
Demineralized bone matrix (DBM) is allograft bone from which the mineral portion has been removed. Bone is approximately 70% mineral by weight. The remaining 30% is collagen and noncollagenous proteins (including bone morphogenetic proteins; BMPs). Prior authors have shown that DBM is effective as a bone graft extender in an animal model 17, 39, 40, 41. While the osteoinductivity of DBM is often assumed, the efficacy of commercially available DBM in a human posterolateral fusion model has not been published in the literature. Commercially available DBM comes in a variety of forms. These forms include injectable gel, flex strips, and putty. Grafton® DBM gel (Osteotech, Eatontown, NJ) was used in this study because of its ability to hold the Pro Osteon 500 granules together cohesively.
Section snippets
Methods
This is a retrospective study of 40 patients. Of the 40 patients, 26 were women and 14 were men with a mean age of 62 years (range, 25–77; median, 68) at the time of surgery. Nineteen patients had had least one prior lumbar surgery. There were nine smokers (22.5%) and seven workman's compensation patients in this population. Eleven of the 40 patients were working at least 6 months before their surgery (6 privately insured, 5 workman's compensation). Primary diagnoses were not disc related and
Results
Mean hospital stay was 6.6 days with a range of 3 to 19 days. Mean blood loss was 184 cc with a range of 25–400 cc. Perioperatively, there were two dural tears, repaired without sequelae. Postoperatively, there was one foot drop, which did not resolve. Mean follow-up in this series was 53 months with a range of 28–70 months.
Patients were asked to identify any current comorbidities at the time of follow-up (Table 1). Thirty-one of the 40 patients indicated they were receiving treatment for at
Discussion
A prospective series comparing autogenous bone with bone graft extenders against a control of autograft alone would have been preferable to a straight retrospective series. However, fusion rates and clinical outcomes of instrumented autogenous posterolateral fusions, as cited previously, are well documented in the literature. The authors realize the limitations of a retrospective study but also recognize that conclusions may still be drawn from a retrospective series with mean follow-up of 4.5
Acknowledgements
The authors wish to thank Marie Hilgar, R.T.R., for taking all radiographs of each patient in this series.
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Research support was provided by Interpore Cross International, Irvine, CA.