Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial

Spine
Hyun W BaeAli Araghi

Abstract

A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates...Continue Reading

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Citations

Oct 31, 2015·The Spine Journal : Official Journal of the North American Spine Society·Michael F ShriverThomas E Mroz
Feb 2, 2017·Neurosurgical Focus·Andrei F Joaquim, K Daniel Riew
Jan 10, 2018·Clinical Spine Surgery : a Spine Publication·Timothy T RobertsEdward C Benzel
Jan 13, 2018·Neurosurgery·Pierce D NunleyMarcus B Stone
Mar 26, 2019·Expert Review of Medical Devices·Siddharth A BadveWilliam F Lavelle
Mar 20, 2019·Spine·Robert A Beatty

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