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Radiographs show Charité discs still mobile after 10 years

Patients who received the Charité TDR had fewer long-term adjacent level problems than fusion patients.

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BERGEN, Norway — A retrospective, multicenter study showed 78.8% of 226 patients implanted with Charité total disc replacement prostheses maintained good or excellent clinical outcomes at over 10 years’ follow-up.

Investigators Thierry David, MD, of Bernard, France, and Jean-Philippe Lemaire, MD, of Dijon, France, submitted cases for the review. They implanted 301 prostheses with noncoated endplates primarily at the L4-5 and L5-S1 levels. Surgeons performed 154 one-level and 72 two-level procedures, and only one three-level procedure, according to the study abstract.

Fabien Bitan, MD, an orthopedic surgeon at Lenox Hill Hospital, New York, presented the study results at the International Society for the Study of the Lumbar Spine 33rd Annual Meeting, here.

Patients had a mean age of 37 years. Of David’s patients, 93% reported excellent or good outcomes at the last follow-up.

Overall, dynamic radiographs showed that 263 implants (87.4%) remained mobile, with flexion/extension averaging 10.2° at the L4-5 level and 7.4° at the L5-S1 level.

The researchers found good to excellent clinical outcomes for 178 of the 226 patients (78.8%). Additionally, 196 of 210 patients (93.3%) who worked prior to surgery had returned to work postoperatively and continued working at last follow-up, according to the study.

Subsidence of undersized implants represented a problem for early investigators. But, “We know now how to avoid this,” Bitan said.

Six patients (2.7%) had adjacent-level disease requiring revision and three patients (1.3%) had immediate subluxation that required revision. Additionally, 19 patients (8.4%) required posterior instrumentation and fusion for continued pain, according to the study.

Other complications included 10 patients (2.3%) who developed facet arthrosis at the implant level. And four patients developed late polyethylene core breakdown at over nine years postop, two of whom surgeons revised to a new prosthesis.

Overall, the results demonstrate the safety and efficacy of Charité TDR, Bitan said.

For more information:

• David T, Lemaire J-P, Moreno P, Bitan F. A long-term multi-center retrospective study of 226 patients with the Charité artificial disc: Minimum 10-year follow-up. #27. Presented at the International Society for the Study of the Lumbar Spine 33rd Annual Meeting. June 14-17, 2006. Bergen, Norway.