Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

Abstract

The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

“…These reports were based upon five independent continuous clinical randomized control trials, reporting for different follow-up periods or containing separated results. Nine reports from the five RCTs with the relevant information are eventually included involving 837 patients [2,3,9,18,20,34,36,41,48].…”

“…In three studies, the ProDisc-L (Synthes Spine, West Chester, PA) [9,48] and FlexiCore (Stryker Spine, Allendale, NJ) [41] artificial disc were employed compared with circumferential fusion. Berg et al [2] performed artificial disc replacement with one of three following devices: CHARITÉ , ProDisc-L, or Maverick (Medtronic, Memphis, TE, USA) compared with the posterolateral fusion (PLF) with autologous bone graft or posterior interbody fusion (PLIF) with two carbon fiber cages. The clinical outcomes, surgical data, and complications were analyzed in 2-or 5-year follow-up period.…”

“…Ten items (10/90, 11.1%) with inconsistent scores were further discussed to reach the consensus. Four studies with 770 patients participated have scored more than 50 points for the 18 questions [2,3,9,48]. One study involving 67 patients has only scored 44 [41].…”

The Michel Benoist and Robert Mulholland Yearly European Spine Journal Review: a survey of the “medical” articles in the European Spine Journal, 2011

“…In a randomized controlled trial with two-year follow-up, Fritzell et al [13] have evaluated the cost-effectiveness of disc prosthesis versus lumbar fusion. This paper is a high-quality economic evaluation, using the clinical data reported in a previous study by Berg et al [4]. The purpose of the present study was (1) to compare the costs associated with disc prosthesis with those of a lumbar fusion, and (2) to compare the costeffectiveness of the two procedures using the EQ-5D.…”

An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease

“…Several randomized [7][8][9][10][11][12] controlled trials have been carried out to compare TDR with lumbar fusion techniques and found no clinically relevant differences in pain or physical function, thus demonstrating that TDR produces at least equivalent clinical results compared with lumbar fusion. Prospective cohort studies of TDR also showed a significant reduction of pain intensity and improvement of functional impairment over short-to midterm follow-up [13][14][15][16][17].…”