Healos/recombinant human growth and differentiation factor-5 induces posterolateral lumbar fusion in a New Zealand white rabbit model

Spine (Phila Pa 1976). 2006 Sep 1;31(19):2180-8. doi: 10.1097/01.brs.0000232823.82106.0a.

Abstract

Study design: Posterolateral lumbar spine fusions in New Zealand white rabbits.

Objective: To evaluate the efficacy of recombinant human growth and differentiation factor-5 (rhGDF-5) lyophilized to a Healos carrier (cross-linked type I collagen with hydroxyapatite coating; DePuy Spine, Inc., Raynham, MA) in inducing fusion.

Summary of background data: Bone graft substitutes have become an area of considerable interest. rhGDF-5 is one such product. Limited lumbar preclinical studies have been performed with this product.

Methods: Single-level, intertransverse process fusions were performed in 67 rabbits using iliac crest autograft (n = 13), Healos alone (n = 13), or 0.5, 1.0, or 1.5 mg/cc rhGDF-5 lyophilized to Healos (n = 13 per group). At 8 weeks, the rabbits were euthanized. Fusion masses were assessed.

Results: There were 2 animals (3%) lost to complication. Manual palpation revealed fusion rates for autograft of 38% (5/13), Healos alone of 0% (0/13), and each of the Healos/rhGDF-5 groups of 100% (13/13). Histologic analyses were 95% sensitive and 95% specific for confirming fusion. Histologic differences were found among the treatment groups.

Conclusions: In this rabbit fusion model, Healos/rhGDF-5 induced fusion in 100% of the rabbits studied. This rate was significantly higher than the fusion rate induced by autograft (38%). Overall, these results support continued research of Healos/rhGDF-5 as a potential bone graft alternative.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Animals
  • Bone Morphogenetic Proteins / pharmacology*
  • Bone Substitutes / pharmacology*
  • Bone Transplantation / methods*
  • Collagen Type I / pharmacology
  • Durapatite / pharmacology
  • Female
  • Growth Differentiation Factor 5
  • Models, Animal
  • Rabbits
  • Recombinant Proteins / pharmacology
  • Spinal Fusion / methods*
  • Spine / drug effects*
  • Transplantation, Autologous

Substances

  • Bone Morphogenetic Proteins
  • Bone Substitutes
  • Collagen Type I
  • GDF5 protein, human
  • Growth Differentiation Factor 5
  • Recombinant Proteins
  • Durapatite