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Implant-related pain, failure seen with early lumbar disc replacement device

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AMSTERDAM — More than one-third of patients treated with one of the first lumbar disc replacement devices underwent revision procedures for implant-related pain or implant failure by the 10-year follow-up, according to a presenter at SpineWeek 2012, here.

Brian J.C. Freeman, MBBS, FRCS(Tr&Orth), presented his team’s experience and data with the AcroFlex lumbar total disc prosthesis (AcroFlex, DePuy Acromed). Investigators used the device to treat chronic discogenic low back pain in 28 patients enrolled in a prospective, non-randomized clinical trial. The patients’ mean age was 41 years and the patients met all the other typical inclusion criteria for such a procedure.

The device was first introduced with flat porous-coated titanium endplates (pilot 1) and subsequent models had contoured plates (pilot 2) with a rubber hexene-base core between them, he said. Eleven patients received the pilot 1 model of implant and the next 17 patients received the pilot 2 model with the contoured endplates.

Freeman said he and his colleagues detected or suspected some problems early on in the series and discontinued using the prosthesis at that time. Some revisions occurred as far out as 8 years after initial implantation, he said. They calculated a cumulative 10-year Kaplan-Meier survival, with first revision as the endpoint, “of 60.7% and 39.3% of subjects undergoing revision,” he said.

“The mean time to first failure was 3 years, 10 months. By comparison, low friction total disc replacement has been reported with revision rates of 7.7% at 5 years. Salvage procedures for the AcroFlex are technically demanding but appear to improve outcomes,” he said.

References:

• Fraser RD, Freeman BJC, Meier AR, Fowler S. 10-year follow-up of AcroFlex lumbar disc replacement. Paper #165. Presented at SpineWeek 2012. May 28-June 1. Amsterdam.
• Fraser R, Ross ER, Lowery GL, et al. AcroFlex design and results. The Spine Journal. 2004;4: S245–S251.
• Disclosure: Freeman received a research grant from Synthes, fellowship support from DePuy Spine, is a consultant to Ranier Technology Ltd., and is a speaker for AOSpine.