Abstract
Controlled trials have shown that total disc replacement (TDR) can provide pain and disability relief to patients with degenerative disc disease; however, whether these outcomes can also be achieved for patients treated in normal surgical practice has not been well documented. This prospective, international study observed changes in disability and back pain in 134 patients who were implanted with Maverick TDR within the framework of routine clinical practice and followed for 2 years post-surgery. Primary and secondary outcomes were the differences from baseline to 6 months post-surgery in the means of the Oswestry Disability Index and the change in back pain intensity assessed on a 10-cm visual analogue scale, respectively. Mean patient age at surgery was 43 years, but ranged up to 65 years. One hundred twenty-three patients had an implant at one level, 10 patients at two levels, and one patient at three levels. Statistically significant improvements in mean disability (-25.4) and low back pain intensity (-4.0) scores were observed at 6 months postoperatively (P < 0.0001 for both) in the hands of experienced surgeons (>10 TDRs per centre). During the study, 56 patients (42 %) experienced a complication or adverse event. This is the first international observational study to report outcomes of TDR in real-world clinical settings. We showed statistically significant improvements in disability and pain scores at 6 months following Maverick TDR, which were maintained for 2 years alongside an acceptable rate of perioperative complications. The safety and tolerability shown in this observational study were comparable to those from controlled trials.
Highlights
We showed statistically significant improvements in disability and pain scores at 6 months following Maverick total disc replacement (TDR), which were maintained for 2 years alongside an acceptable rate of perioperative complications
Since 50 years, a pathologic disc associated with lumbar degenerative disc disease (DDD) that did not respond to conservative care has been preferentially treated by spinal fusion
Patients were enroled by signing informed consent and having their data entered in the electronic case report form
Summary
Since 50 years, a pathologic disc associated with lumbar degenerative disc disease (DDD) that did not respond to conservative care has been preferentially treated by spinal fusion. Disc replacement can provide pain relief by resecting the diseased intervertebral disc and dynamically stabilising the segment, allowing restoration and maintenance of spine biomechanics. Compared to fusion, this is expected to reduce the incidence of adjacent segment degeneration [5,6,7]. The Maverick disc, a two-piece lumbar disc prosthesis, can be implanted at any spinal level from T12/L1 to L5/S1. It has a semi-constrained metal-on-metal design, preserving motion by a ball-and-socket construct with a physiological posterior centre of rotation [8]. A 2-year randomised controlled trial (RCT) demonstrated statistical superiority of Maverick over spinal fusion based on key clinical outcomes, including disability and pain [9]
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