For patients with disease at multiple spinal levels, surgeons have traditionally faced a binary choice: fuse everything or disc replacement. Ramin Raiszadeh, MD, of San Diego Spine and Brain Institute, said he now routinely does both in the same operation — a technique he calls a hybrid construct.
The hybrid construct
The approach combines fusion at one spinal level with disc replacement at an adjacent level, in a single surgery. Dr. Raiszadeh described a common scenario: a patient with a congenital instability at one level requires fusion, alongside a separate, worn-out disc at the level above it. Historically, he said, the standard approach would be to fuse both levels.
“Sometimes as spine surgeons we’re told that we are supposed to work within the confines of the box. So the FDA says, OK, you can only use this device for these specific indicated solutions,” he said.
However, he said instead of defaulting to fusion, he approaches the fusion versus disc replacement question from an “off-label” perspective. He fuses only the unstable level and replaces the disc at the adjacent one — preserving motion at the level next to that.
“I could stabilize … but if I could do a [disc replacement] of L4 or 5, I could potentially preserve L3-L4 for that patient,” he said. “Huge advantage.”
He described a similar approach for multi-level neck disease. Where a four-level fusion was once the standard, he said a hybrid construct — fusing some levels while replacing discs at others — can preserve motion at the levels that don’t require stabilization.
The off-label question
Disc replacement devices currently carry FDA approval, or “on-label” use, for one or two continuous spinal levels — not for combination with fusion in the same setting. Dr. Raiszadeh was direct that performing a hybrid construct is off-label use of the disc replacement device. “So sometimes I think we have to think outside the box,” he said, “but you have to be able to discuss [it] with the patient …. The patient has to know the ins and outs of these indications.” He said patients need to be informed specifically about what is on-label and off-label, and understand the associated issues, before proceeding.
Getting it authorized
Off-label use is sometimes assumed to face greater insurance scrutiny than approved procedures. Dr. Raiszadeh said that despite this, he has not run into approval issues. “I routinely do hybrid constructs, I get authorized all the time.” he said.
He said that he is surprised he does not see the procedure more often. “I don’t see [it] as much” among other surgeons, he added, suggesting it may be underused elsewhere despite what he described as reliable authorization in his own practice.
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