AcroFlex design and results.
The AcroFlex prosthesis is unique when compared to other current devices, as it has an elastomeric core sandwiched between two titanium endplates. The purpose of this design was to optimize shock absorption qualities. This paper reviews the design of the AcroFlex Disc and relevant design and outcomes of two pilot studies carried out on 28 patients using the AcroFlex prosthesis. Although clinical outcomes of the pilot studies were successful, the pivotal randomized trial has not been carried out due to detection of mechanical failure of the elastomer on thin cut CT scans. The implications of this for the AcroFlex and other arthroplasties are discussed.
Fraser
Robert D
RD
Department of Orthopaedics and Trauma, Bice Building, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia. rdf@adelaide.on.net
Ross
E Raymond
ER
Lowery
Gary L
GL
Freeman
Brian J
BJ
Dolan
Mark
M
D000328:Adult; D019643:Arthroplasty, Replacement / Q000295:instrumentation*; D001672:Biocompatible Materials / Q000627:therapeutic use; D020724:Elastomers / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007403:Intervertebral Disc; D007595:Joint Prosthesis; D008159:Lumbar Vertebrae; D008875:Middle Aged; D010003:Osteoarthritis / Q000601:surgery; D010865:Pilot Projects; D011474:Prosthesis Design; D014025:Titanium / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed
D001672:Biocompatible Materials; D020724:Elastomers; D014025:Titanium