Efficacy of interspinous process lumbar fusion with recombinant human bone morphogenetic protein-2 delivered with a synthetic polymer and β-tricalcium phosphate in a rabbit model.
BACKGROUND
As a powerful bone-inducing cytokine, rhBMP-2 has been used as a bone graft substitute in combination with animal-derived collagen to achieve interbody or posterolateral spinal fusion. Successful interspinous process fusion using rhBMP-2 in combination with synthetic carrier materials would offer a safe, minimally invasive spinal fusion option for the treatment of spinal disorders. The aims of the present study were to achieve interspinous process fusion by implanting rhBMP-2-retaining degradable material instead of bone grafting and to evaluate efficacy for vertebral stabilization.


METHODS
A polymer gel (200 mg), β-tricalcium phosphate powder (400 mg), and rhBMP-2 (0, 30, 60 or 120 μg) were mixed to generate a plastic implant, which was then placed during surgery to bridge the L5-6 interspinous processes of 58 rabbits. Control animals received implants either without rhBMP-2 or with autogenous bone chips from the iliac crest. L5-6 vertebrae were recovered 8 weeks postoperatively. Interspinous process fusion was evaluated by radiography, biomechanical bending test, intradiscal pressure (IDP) measurement, and histology.


RESULTS
In bending tests, strength of fusion was significantly greater in BMP60 and BMP120 groups than in sham, BMP0, BMP30 or autogenous bone groups. IDP at L5-6 was significantly reduced in BMP60 and BMP120 groups compared to sham, BMP0, BMP30, and autograft groups. Histologically, coronal sections of the fusion mass showed a bone mass bridging both spinous processes.


CONCLUSIONS
Solid interspinous process fusion was achieved in rabbit models by 8 weeks after implanting the biodegradable bone-inducing material. These results suggest a potential new less-invasive option without bone grafting for the treatment of lumbar disorders.
Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan.
Tomiya
T
Matsumoto
Hiromitsu
H
Toyoda
Sho
S
Dohzono
Hiroyuki
H
Yasuda
Shigeyuki
S
Wakitani
Hiroaki
H
Nakamura
Kunio
K
Takaoka
D000818:Animals; D001672:Biocompatible Materials / Q000627:therapeutic use; D001696:Biomechanical Phenomena; D055396:Bone Morphogenetic Protein 2 / Q000627:therapeutic use*; D002130:Calcium Phosphates / Q000627:therapeutic use*; D007773:Lactates / Q000627:therapeutic use*; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D023421:Models, Animal; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011817:Rabbits; D011859:Radiography; D011994:Recombinant Proteins / Q000627:therapeutic use; D013123:Spinal Fusion / Q000379:methods*; D016896:Treatment Outcome
C525718:BMP2 protein, human; D001672:Biocompatible Materials; D055396:Bone Morphogenetic Protein 2; D002130:Calcium Phosphates; D007773:Lactates; D011994:Recombinant Proteins; C485817:beta-tricalcium phosphate; C088513:poly(lactic acid-ethylene glycol); D011092:Polyethylene Glycols