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Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials.

ABSTRACT: Study Design:Meta-analysis. Objectives:To evaluate the long-term efficacy and safety of total disc replacement (TDR) compared with fusion in patients with functionally disabling chronic low back pain due to single-level lumbar degenerative disc disease (DDD) at 5 years. Methods:PubMed and Cochrane Central Register of Controlled Trials databases were searched for randomized controlled trials reporting outcomes at 5 years for TDR compared with fusion in patients with single-level lumbar DDD. Outcomes included Oswestry Disability Index (ODI) success, back pain scores, reoperations, and patient satisfaction. All analyses were conducted using a random-effects model; analyses were reported as relative risk (RR) ratios and mean differences (MDs). Sensitivity analyses were conducted for different outcome definitions, high loss to follow-up, and high heterogeneity. Results:The meta-analysis included 4 studies. TDR patients had a significantly greater likelihood of ODI success (RR 1.0912; 95% CI 1.0004, 1.1903) and patient satisfaction (RR 1.13; 95% CI 1.03, 1.24) and a significantly lower risk of reoperation (RR 0.52; 95% CI 0.35, 0.77) than fusion patients. There was no association with improvement in back pain scores whether patients received TDR or fusion (MD -2.79; 95% CI -8.09, 2.51). Most results were robust to sensitivity analyses. Results for ODI success and patient satisfaction were sensitive to different outcome definitions but remained in favor of TDR. Conclusions:TDR is an effective alternative to fusion for lumbar DDD. It offers several clinical advantages over the longer term that can benefit the patient and reduce health care burden, without additional safety consequences.

SUBMITTER: Zigler J

PROVIDER: S-EPMC6022955 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials.

Zigler Jack J Gornet Matthew F MF Ferko Nicole N Cameron Chris C Schranck Francine W FW Patel Leena L

Global spine journal 20171116 4

<h4>Study design</h4>Meta-analysis.<h4>Objectives</h4>To evaluate the long-term efficacy and safety of total disc replacement (TDR) compared with fusion in patients with functionally disabling chronic low back pain due to single-level lumbar degenerative disc disease (DDD) at 5 years.<h4>Methods</h4>PubMed and Cochrane Central Register of Controlled Trials databases were searched for randomized controlled trials reporting outcomes at 5 years for TDR compared with fusion in patients with single-l ...[more]

PMID: 29977727

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Project description:PurposeTo systematically compare the efficacy and safety of lumbar total disc replacement (TDR) with the efficacy and safety of anterior lumbar interbody fusion (ALIF) for the treatment of lumbar degenerative disc disease (LDDD).MethodsThe electronic databases PubMed, Web of Science and the Cochrane Library were searched for the period from the establishment of the databases to March 2018. The peer-reviewed articles that investigate the safety and efficacy of TDR and ALIF were retrieved under the given search terms. Quality assessment must be done independently by two authors according to each item of criterion. The statistical analyses were performed using RevMan (version 5.3) and Stata (version 14.0). The random-effect model was carried out to pool the data. The I2 statistic was used to evaluate heterogeneity. The sensitivity analysis was carried out to assess the robustness of the results of meta-analyses by omitting the articles one by one.ResultsSix studies (5 randomized controlled trials (RCT) and 1 observational study) involving 1093 patients were included in this meta-analysis. The risk of bias of the studies could be considered as low to moderate. Operative time (MD = 4.95; 95% CI -18.91-28.81; P = 0.68), intraoperative blood loss (MD = 4.95; 95% CI -18.91-28.81; P = 0.68), hospital stay (MD = -0.33; 95% CI, -0.67-0.01; P = 0.05), complications (RR = 0.96; 95% CI 0.91-1.02; P = 0.18) and re-operation rate (RR = 0.54; 95% CI 0.14-2.12; P = 0.38) were without significant clinical difference between groups. Patients in the TDR group had higher postoperative satisfaction (RR = 1.19; 95% CI 1.07-1.32; P = 0.001) and, better improvements in ODI (MD = -10.99; 95% CI -21.50- -0.48; P = 0.04), VAS (MD = -10.56; 95% CI -19.99- -1.13; P = 0.03) and postoperative lumbar mobility than did patients in the ALIF group.ConclusionsThe results showed that TDR has significant superiority in term of reduced clinical symptoms, improved physical function and preserved range of motion for the treatment of LDDD compared to ALIF. TDR may be an ideal alternative for the selected patients with LDDD in the short-term. However, the results of this study cannot suggest the use of TDR instead of ALIF in lumbar spine treatment only in the light of short term results. More studies that are well-designed, that are of high-quality and that have larger samples are needed to further evaluate the efficacy and safety of TDR with at the long-term follow-up.Level of evidenceTherapeutic Level 3.

Project description:BackgroundThe motion preserving benefits of lumbar total disc replacement (LTDR) are well established. There is a paucity of long-term follow-up data on the M6-L prosthesis. The aim was to evaluate the clinical and radiographic outcomes of patients undergoing LTDR with M6-L and make comment about its effectiveness and durability.MethodsA retrospective single center chart review was performed of all patients who underwent LTDR with M6-L between January 1, 2011, and January 1, 2021, either as standalone device or combined with a caudal anterior lumbar interbody fusion (ALIF) (hybrid procedure). Preoperative, postoperative, and final follow-up patient reported outcome measures (PROMs) (VAS back, VAS leg, ODI, and SF-12) and patient satisfaction were recorded prospectively. Device range of motion (ROM), adjacent segment degeneration/disease and heterotopic ossification (HO) were obtained from flexion and extension lumbar radiographs at most recent follow-up.ResultsSixty patients underwent LTDR with the M6-L device. Mean age was 41 [16-71] years and 38 (63%) were male. Sixteen (26.7%) underwent standalone LTDR, 42 (70.0%) a hybrid procedure, and 2 (3.3%) a 3-level procedure. Twenty-three (38.3%) patients were lost to follow-up. Thirty-seven (61.7%) were followed for a mean of 4.3 [1-10] years with 36/37 reviewed at a minimum of 2-years and 13/37 followed for over 5-years. Only one patient with osteopenia needed index level revision LTDR surgery for subsidence requiring supplemental posterior instrumentation. There were no osteolysis induced device related failures. Thirty patients obtained long-term follow-up radiographic data. Six patients had adjacent segment degeneration; none required surgery for adjacent segment disease (ASD). Three patients presented with clinically significant HO (2 with McAfee class III, 1 with class IV). The average M6-L ROM was 8.6 degrees. Mean preoperative baseline PROMs demonstrated statistically significant improvements postoperatively and were sustained at last follow-up (P<0.05).ConclusionsTotal disc replacement (TDR) with M6-L showed clinically significant improvement in PROMs that were sustained at long-term follow-up. There were no osteolysis induced device related failures. The device ROM was maintained and showed a downward trend over the 10-year study follow-up period. This paper demonstrated that the M6-L was an effective and durable arthroplasty device in this series.

Project description:BackgroundDuring lumbar spinal fusion, spacer cages are implanted to provide vertebral stability, restore sagittal alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used by most spine surgeons. Silicon nitride (Si3N4) is a less well-known alternative although it was first used as a spacer in lumbar fusion over 30 years ago. The present study was designed to see if Si3N4 cages would perform similarly to PEEK in a randomized controlled trial.MethodsA non-inferiority multicenter 100-patient study was designed where both the observer and patient were blinded. Single- or double-level transforaminal lumbar interbody fusion with pedicle screw fixation using an oblique PEEK or Si3N4 cage was performed. The primary non-inferiority outcome was the Roland-Morris Disability Questionnaire (RMDQ). Secondary measures included the Oswestry Disability Questionnaire, Visual Analogue Scales (VAS) for back and leg pain, SF-36 Physical and Mental Function indices, patient and surgeon Likert scores on perceived recovery, and X-ray and CT radiological evaluations for subsidence, segmental motion, and fusion. Follow-up evaluations occurred at 3, 6, 12, and 24 months.ResultsAfter exclusions for protocol violations and canceled surgeries, 92 patients were randomized (i.e., 48 for PEEK and 44 for Si3N4). There were no differences in baseline demographics, pre-operative disabilities, or pain scores between the groups. Both treatment arms showed significant improvements in disability, pain, and recovery scores. No significant differences were observed for subsidence, segmental motion, or fusion. For the primary outcome (i.e., RMDQ scores), the non-inferiority of Si3N4 compared to PEEK could not be established using the original protocol criteria. However, the comparison was undermined by larger than anticipated patient fallout coupled with higher than expected RMDQ score standard deviations. A post hoc analysis coupled with a more extensive review of the literature was conducted which resulted in the selection of a revised clinically justified non-inferiority margin; and using this method, the non-inferiority of Si3N4 was affirmed.ConclusionsThis study demonstrated that the use of either PEEK or Si3N4 cages is safe and effective for patients undergoing lumbar spine fusion for chronic degenerative disc disease.

Dataset Information

Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials.

Publications

Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials.

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