Elsevier

The Spine Journal

Volume 1, Issue 2, March–April 2001, Pages 131-137
The Spine Journal

Original submission
Instrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix, as an adjunct to autologous bone

https://doi.org/10.1016/S1529-9430(01)00011-0Get rights and content

Abstract

Background context: Autogenous posterolateral fusion with and without instrumentation has been reported with good results. However, difficult-to-fuse patients, such as smokers, elderly patients with poor bone quality and/or quantity, or patients with prior posterior surgeries, may have somewhat lower fusion rates.

Purpose: To determine the efficacy of coralline hydroxyapatite with or without demineralized bone matrix as a bone graft extender in a human clinical model with long-term follow-up. Study design/setting: A retrospective series of 40 patients undergoing instrumented autogenous posterolateral lumbar fusion augmented with coralline hydroxyapatite with or without demineralized bone matrix. Patient sample: Long-term clinical and radiographic follow-up were examined for 40 patients who underwent an instrumented posterolateral fusion only. Patients undergoing anterior lumbar interbody fusion (ALIF) procedures were not considered part of the sample. Methods: All patients underwent successful transpedicular fixation with autogenous posterolateral lumbar fusion. Fifteen cc of Pro Osteon™ 500 coralline hydroxyapatite (Interpore Cross International, Irvine, CA) was used at each level. An additional 10 cc of Grafton demineralized bone matrix gel (Osteotech, Eatontown, NJ) was used in 70% of these patients. Results: An overall fusion rate of 92.5% was achieved. Pain and function improvement were good but somewhat age dependent and correlated with the number of comorbidities. Patients with Grafton DBM gel had a lower fusion rate of 89.3%. Conclusions: Based on this small retrospective review, coralline hydroxyapatite is an effective bone graft extender in difficult-to-fuse patients as an adjunct to autologous bone for posterolateral fusion of the lumbar spine when combined with rigid instrumentation.

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.

References (47)

  • J.C. France et al.

    A randomized prospective study of posterolateral lumbar fusion. Outcomes with and without pedicle screw instrumentation

    Spine

    (1999)
  • C.G. Greenough et al.

    Instrumented posterolateral lumbar fusion. Results and comparison with anterior interbody fusion

    Spine

    (1998)
  • Rompe JD, Eysel P, Hopf C. Clinical efficacy of pedicle instrumentation and posterolateral fusion in the symptomatic...
  • J.S. Thalgott et al.

    Adult spondylolisthesis treated with posterolateral lumbar fusion and pedicular instrumentation with AO DC plates

    J Spinal Disord

    (1997)
  • K. Thomsen et al.

    1997 Volvo Award winner in clinical studies. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spine fusiona prospective, randomized clinical study

    Spine

    (1997)
  • P. Axelsson et al.

    Posterolateral lumbar fusion. Outcome of 71 consecutive operations after 4 (2–7) years

    Acta Orthop Scand

    (1994)
  • J.Y. Hayes

    Dorsolumbar spinal fusion utilizing a posterolateral approach

    Univ Mich Med Bull

    (1961)
  • R. Johnsson et al.

    Posterolateral lumbar fusion using facet joint fixation with biodegradable rodsa pilot study

    Eur Spine J

    (1997)
  • S.S. Jorgenson et al.

    A prospective analysis of autograft versus allograft in posterolateral lumbar fusion in the same patient. A minimum of 1-year follow-up in 144 patients

    Spine

    (1994)
  • R.N. Stauffer et al.

    Posterolateral lumbar-spine fusion. Analysis of Mayo Clinic series

    J Bone Joint Surg

    (1972)
  • N. Tajima et al.

    Posterolateral fusion of the lumbar and lumbosacral spine—a review of long-term results

    Nippon Seikeigeka Gakkai Zasshi

    (1989)
  • G. Truchly et al.

    Posterolateral fusion of the lumbosacral spine

    J Bone Joint Sur

    (1962)
  • A. Unnanantana

    Posterolateral lumbar fusion for degenerative spondylolisthesisexperiences of a modified technique without instrumentation

    J Med Assoc Thai

    (1997)
  • Cited by (66)

    • Demineralized Bone Matrix Bone Biology and Clinical Use

      2016, Seminars in Spine Surgery
      Citation Excerpt :

      All 51 products have obtained either FDA 510(k) approval or are marketed as human tissues for transplantation subject to the Code of Federal Regulations (CRF) 1270 (Human Tissue Intended for Transplantation)16 and 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products).26 As of April 2016, there are 29 peer-reviewed published studies reporting clinical data on the use of DBM-based products from seven different manufacturers as spinal fusion adjuncts in 1503 patients,27–55 not including comparative or control group patients. These include 15 observational studies with 867 patients and 14 comparative studies with 636 patients [192 (RCT), 73 (prospective studies), and 371 (retrospective studies)] (Table 2).

    • Is there a role of coral bone substitutes in bone repair?

      2016, Injury
      Citation Excerpt :

      Therefore, due to the fact that calcium carbonate can be resorbed faster than calcium phosphate, the graft can facilitate the remodeling allowing more effective bone ingrowth within the graft material. There have been a number of clinical studies analyzing the effectives of Pro Osteon™ in a range of clinical applications (Table 1) [56–73]. The majority of the studies involve cases of periodontal and maxillofacial defects.

    • A review of demineralized bone matrices for spinal fusion: The evidence for efficacy

      2013, Surgeon
      Citation Excerpt :

      DBM has also been evaluated in the lumbar spine, with early studies yielding conflicting results on the efficacy of DBM as a graft extender. Thalgott and colleagues found a higher rate of pseudarthrosis with the use of Grafton gel-DBM and coralline hydroxyapatite as compared with coralline hydroxyapatite alone in a retrospective study of 40 patients who underwent instrumented posterolateral lumbar spinal fusion.42 In contrast, Sassard and colleagues43 and Girardi and Cammisa reported case series with promising results for the use of DBM as a graft extender in the lumbar spine.44

    • Demineralized Bone Matrix and Fibers in Spinal Fusion

      2023, International Journal of Spine Surgery
    View all citing articles on Scopus

    Research support was provided by Interpore Cross International, Irvine, CA.

    View full text