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Titanium cages for spinal fusion may increase cost with little benefit to patient

Fusion with titanium cage does not achieve accepted mean clinically important differences.

Issue: Issue 5 2005

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Titanium cages of various designs for spinal fusion have become widespread. Many trials with titanium cages yield impressive clinical results, yet there are no controlled trials in circumferential fusion, and the cost of these cages is barely addressed.

Brian Freeman, FRCS, of The Centre for Spinal Studies and Surgery, Queens Medical Centre, Nottingham, England, presented the results of a two-year study comparing a femoral ring allograft to a titanium cage in circumferential lumbar spinal fusion — the first such comparative, prospective trial. He spoke during the International Society for the Study of the Lumbar Spine 32nd Annual Meeting.

Both methods yield good results, but the femoral ring costs $228 vs. $2280 for the cage, Freeman said. “If there was an observed difference in clinical outcome between these implants, the null hypotheses would be rejected and perhaps the cost of the titanium cage could be justified.”

The 83 patients recruited into this prospective study fulfilled strict entry requirements (greater than six months chronic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic pain source). Of these patients, 38 were randomized to receive femoral ring allograft, and 45 were randomized to receive a titanium cage.

Posterior stabilization was achieved with either translaminar or pedicle screws. Primary measure was the Oswestry Disability Index (ODI) with a 10-point change regarded as clinically relevant. Secondary outcome measures included the Visual Analog Scale (VAS) for back and leg pain (clinically relevant change, two points) and Short-Form 36 (SF-36), with seven-point change regarded as clinically relevant. The outcome measures were assessed preoperatively and at six, 12 and 24 months, postoperatively.

“For patients who received the femoral ring allograft, mean VAS (back pain) improved 2.0 points, mean ODI improved 15 points, and mean SF-36 scores improved by more than 11 points,” Freeman said. Patients who received the titanium cage improved 1.2 points in VAS, five points mean ODI, and improved significantly in only two of eight domains (bodily pain and physical function) in SF-36. Overall implant cost for each arm of the trial was $11,856 for the femoral ring allograft group and $136,800 for the titanium cage group.

“Lumbar fusion with femoral ring allograft readily achieved the accepted mean clinically important differences, while fusion with titanium cages did not,” Freeman said. “In this trial, the use of the titanium cages in circumferential lumbar fusion cannot be justified on the basis of inferior clinical outcome and excessive cost.”

For more information:

• Freeman B. A prospective randomized trial femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion. #8. Presented at the International Society for the Study of the Lumbar Spine 32nd Annual Meeting. May 10-14, 2005. New York.