A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion

Abstract

The objective of this study was to establish the efficacy and safety of porous bioactive titanium metal for use in a spinal fusion device, based on a prospective human clinical trial. A high-strength spinal interbody fusion device was manufactured from porous titanium metal. A bioactive surface was produced by simple chemical and thermal treatment. Five patients with unstable lumbar spine disease were treated surgically using this device in a clinical trial approved by our Ethics Review Committee and the University Hospital Medical Information Network. Clinical and radiological results were reported at the minimum follow-up period of 1 year. The optimal mechanical strength and interconnected structure of the porous titanium metal were adjusted for the device. The whole surface of porous titanium metal was treated uniformly and its bioactive ability was confirmed before clinical use. Successful bony union was achieved in all cases within 6 months without the need for autologous iliac crest bone grafting. Two specific findings including an anchoring effect and gap filling were evident radiologically. All clinical parameters improved significantly after the operation and no adverse effects were encountered during the follow-up period. Although a larger and longer-term follow-up clinical study is mandatory to reach any firm conclusions, the study results show that this porous bioactive titanium metal is promising material for a spinal fusion device.

Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation

“…Ti became a ''gold standard'' material in orthopedics subsequent to the discovery of its osseointegration capacity [23]. Its suitability to spinal applications is attributed to additional properties of biocompatibility, corrosion resistance and low density.…”

“…Its suitability to spinal applications is attributed to additional properties of biocompatibility, corrosion resistance and low density. However, the discrepancy in titanium's elastic modulus comparative to bone (116-17.7 GPa) is a significant disadvantage, potentially causing stress shielding, subsidence and implant failure [7,23,24].…”

Enhanced healing of rabbit segmental radius defects with surface-coated calcium phosphate cement/bone morphogenetic protein-2 scaffolds

“…As the most representative bone growth factor, recombinant human BMP-2 (rhBMP-2) has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of spinal fusion and tibial fractures combined with a matrix like collagen or decalcified bone [20][21][22]. However, rhBMP-2 has a short half-life and always appears bolus release at a very early period which may impair the bone regeneration.…”

Role of integrin α2β1 in mediating osteoblastic differentiation on three‐dimensional titanium scaffolds with submicron‐scale texture

“…16–20 Porous materials have been used for bone tissue engineering. Ceramics with similar mineral to that of bone, such as hydroxyapatite and beta-tricalcium phosphate, are biocompatible and have been used clinically with bone marrow-derived osteoprogenitor cells to treat bone defects.…”