STUDY DESIGN: Explant analysis for bone ingrowth of retrieved cervical disc prosthesis in chimpanzees and humans. OBJECTIVES: To assess the bone ingrowth into retrieved Bryan Cervical Discs. SUMMARY OF BACKGROUND DATA: Bone ingrowth in cervical disc prosthesis has not been documented in the literature. METHODS: Chimpanzee: Two chimpanzees underwent placement of the Bryan disc at C3-C4 and 3 months later had explantation and interbody fusion. Human: Two patients had removal of their Bryan disc and interbody fusion for failure to resolve symptoms at 8 and 10 months. The explants were analyzed for bone ingrowth. RESULTS: Chimpanzee: Histologic analysis showed bony ingrowth through the interstices of the porous coating and apposition ranging from 10% to 50% of toluidine blue-stained sections. New ingrowth, rather than bony impaction, was confirmed with fluorochrome-labeled sections Human: Bone ingrowth was a mean of 30.1% (12% SD). No difference was observed between peripheral, intermediate, or central locations. CONCLUSIONS: Adequate bony apposition was found in all primate device-to-vertebral body interfaces. Human retrievals also demonstrated significant ingrowth in all four surfaces. This compares with hip and knee arthroplasty percent ingrowth rates of 10% to 30%. All implants had stable fixation judged by radiographs and at the time of implant removal.
STUDY DESIGN: Explant analysis for bone ingrowth of retrieved cervical disc prosthesis in chimpanzees and humans. OBJECTIVES: To assess the bone ingrowth into retrieved Bryan Cervical Discs. SUMMARY OF BACKGROUND DATA: Bone ingrowth in cervical disc prosthesis has not been documented in the literature. METHODS:Chimpanzee: Two chimpanzees underwent placement of the Bryan disc at C3-C4 and 3 months later had explantation and interbody fusion. Human: Two patients had removal of their Bryan disc and interbody fusion for failure to resolve symptoms at 8 and 10 months. The explants were analyzed for bone ingrowth. RESULTS:Chimpanzee: Histologic analysis showed bony ingrowth through the interstices of the porous coating and apposition ranging from 10% to 50% of toluidine blue-stained sections. New ingrowth, rather than bony impaction, was confirmed with fluorochrome-labeled sections Human: Bone ingrowth was a mean of 30.1% (12% SD). No difference was observed between peripheral, intermediate, or central locations. CONCLUSIONS: Adequate bony apposition was found in all primate device-to-vertebral body interfaces. Human retrievals also demonstrated significant ingrowth in all four surfaces. This compares with hip and knee arthroplasty percent ingrowth rates of 10% to 30%. All implants had stable fixation judged by radiographs and at the time of implant removal.
Authors: R Dana Carpenter; Brett S Klosterhoff; F Brennan Torstrick; Kevin T Foley; J Kenneth Burkus; Christopher S D Lee; Ken Gall; Robert E Guldberg; David L Safranski Journal: J Mech Behav Biomed Mater Date: 2018-04