Intervertebral Spacer as an Adjunct to Anterior Lumbar Fusion. Part II. Six-Month Implantation in Baboons

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Failure of interbody fusions in the lumbar spine are common due to reliance on the graft for structural support during healing by creeping substitution. Support of the interspace with an implant should result in improved fusion success. The objective of this study was to evaluate the stability of the implant in vivo and its potential as an adjunct to promote interbody arthrodesis. Prototype 3, a porous coated intervertebral spacer with extension lugs made of Ti-6AI-4V, was implanted vertically between adjacent lumbar vertebrae anteriorly in four baboons undergoing anterior interbody fusion. The animals were allowed freedom of activity for 6 months before being killed. A transperitoneal approach was made exposing the L4-L5 or L5-L6 interspace. At time of killing, clinical evaluation of the implant-vertebral body construct showed stability to manual stresses applied in extension, flexion, and rotation. Serial radiographs taken during the 6 months of implantation showed no change in position or displacement of the implants. Axial and torsional cyclic loads were applied to each spine at 1 cycle/s for 20,000 cycles. Statistical analysis of the motion profiles for intact and implanted spines demonstrated no significant difference in axial or rotational displacements at the arthrodesis level or adjacent unoperated levels, L1 and L4. The in vivo 6-month study in baboons confirmed implant stability and maintenance of disc space height. Variable osseous healing was noted. Release of plasma spray beading may have resulted from improper application on the implant or micromotion within the construct. A better method to mechanically interlock the plungers is being studied. Clinical trials based on this work appear justified.

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