Ostene, water soluble bone hemostasis material, bone wax alternative

SUSCEPTIBILITY TO BONE INFECTION was evaluated in a rabbit tibial model.
Cortical bone defects were created in the proximal tibia in 24 rabbits. The defects were either treated with bone wax, Ostene, or left without a hemostatic agent, and all were innoculated with Staph aureus.
After 4 weeks all defects containing bone wax became infected and developed osteomyelitis, with destruction of the bone marrow, abscess formation, periosteal reaction, and bone lysis. There was no bone healing in any of the defects treated with bone wax.
In the Ostene and control groups, 2 defects in each group (25%) developed osteomyelitis. The remaining 6 defects in each group (75%) showed no evidence of osteomyelitis, and all exhibited normal bone healing.
The application of bone wax to the cortical defect significantly increased the osteomyelitis rate (p ≤ .004). There was no difference between the Ostene group and the control group in the rates of osteomyelitis, positive cultures, or bone healing.

	CRANIAL BONE HEALING was evaluated using a rat model at UCLA.¹ Seventeen 3 mm calvarial defects were created in rat calvaria. The amount of new bone formation at 3 weeks was calculated using micro-CT data. The amount of new bone formation filling the defects is shown above. The Ostene filled defects had significantly more bone formation than those filled with bone wax (p ≤ .001).

	STERNAL BONE HEALING was evaluated in a rabbit sternotomy model.² Median sternotomies were performed on 20 rabbits, and hemostasis was achieved using either bone wax or Ostene. After 6 weeks the Ostene treated sternums were significantly stronger (p ≤ .001) with twice the strength of bone wax treated ones. The bone wax treated sternums had fibrous tissue and residual wax interfering with healing. The Ostene group healed normally.

TIBIAL BONE HEALING was evaluated in a rabbit model.³Twenty-four 3 mm circular cortical defects were created in proximal tibias of rabbits.
Immediate hemostasis was achieved with either Ostene or a microfibrillar collagen hemostat. After 17 days, bone healing was measured quan-titatively using micro-CT. Near complete bone
healing occurred in the Ostene treated group, with little healing in the microfibrillar collagen group. Compared to Ostene, osteogenesis was significantly impaired by microfibrillar collagen (p < .0001).

INFLAMMATORY PROPERTIES of bone hemostasis agents were evaluated in a number of animal and human studies.⁴
Ostene is non-inflammatory. Studies have shown that bone wax, gelatin sponges, collagen and oxidized cellulose may lead to chronic inflammatory reactions and/or interfere with bone healing.⁵ Inflammation and swelling are particularly problematic in closed spaces such as those encountered in the cranium and spine.

1. Magyar CE, Aghaloo TL, Atti E, Tetradis S: Ostene, a New Water Soluble Wax for Bone Hemostasis, Does Not Inhibit Bone Healing, presented at the 2007 American Association of Neurological Surgeons Annual Meeting. Washington DC, April 17, 2007.

2. Armstrong JK, Fisher TC, Cambridge JS, et al.: The Effects Of Bone Wax And Ostene, A Newly Available Water-Soluble Synthetic Bone Hemostasis Material, On Sternal Healing Following Median Sternotomy In An Animal Model, presented at the 87th Annual Meeting of the American Society for Thoracic Surgery. Washington DC, May 5, 2007.

3. Wellisz T, An YH, Wen X, et al.: Infection Rates and Healing Using Bone Wax and a Soluble Polymer Material. Clin Orthop Relat Res 2008:466:481–486.

4. Wellisz T, Armstrong JK, Cambridge J, Fisher TC: Ostene, a new water-soluble bone hemostasis agent. J Craniofac Surg 2006:17:420-425.

5. Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A: The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J 2004:13 Suppl 1:S89-96.

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*As shown in animal studies, actual clinical effects of these results remain unknown, data available upon request.