Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial

Neurosurgery 88:497–505, 2021

Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration.

OBJECTIVE: To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology.

METHODS: This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C ®  Cervical Disc (Zimmer Biomet).  Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr.

RESULTS: At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr.

CONCLUSION: Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C ® continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

 

The Effect of Older Age on the Perioperative Outcomes of Spinal Fusion Surgery in Patients With Lumbar Degenerative Disc DiseaseWith Spondylolisthesis

Neurosurgery, Volume 87, Issue 4, 1 October 2020, Pages 672–678

Degenerative spondylolisthesis (DS) is often treated with lumbar spinal fusion (LSF). However, there is concern that the morbidity of LSF may be prohibitively high in older adults.

OBJECTIVE: To evaluate the impact of advanced age on the safety of LSF for DS.

METHODS: Patients who underwent LSF for DS were retrospectively identified from National Surgical Quality Improvement Program datasets for 2011 to 2015 using Current Procedural Terminology codes. Data on demographic characteristics, comorbidities, surgical factors, and 30-d morbidity and mortality were collected. Propensity score matching (nearest neighbor) was performed with age (<70 vs ≥70 yr) as the dependent variable and sex, type of fusion procedure, number of levels fused, diabetes, smoking, hypertension, and chronic steroid use as covariates. Outcomes were compared between age <70 and ≥70 groups.

RESULTS: The study cohort consisted of 2238 patients (n=1119, age<70; n=1119, age≥70). The 2 age groups were balanced for key covariates including sex, race, diabetes, hypertension, CHF, smoking, chronic steroid use, type of fusion, and number of levels. Rates of all complications were similar between younger and older age groups, except urinary tract infection, which was more frequent among the ≥70 age group (OR 2.32, P = .009). Further, patients in the older age group were more likely to be discharged to a rehabilitation (OR 2.94, P < .001) or skilled care (OR 3.66, P < .001) facility, rather than directly home (OR 0.25, P < .001).

CONCLUSION: LSF may be performed safely in older adults with DS. Our results suggest older age alone should not exclude a patient from undergoing lumbar fusion for DS.

Functional and radiological outcome of anterior retroperitoneal versus posterior transforaminal interbody fusion in the management of single-level lumbar degenerative disease

Neurosurg Focus 49 (3):E2, 2020

In this study the authors compared the anterior lumbar interbody fusion (ALIF) and posterior transforaminal lumbar interbody fusion (TLIF) techniques in a homogeneous group of patients affected by single-level L5–S1 degenerative disc disease (DDD) and postdiscectomy syndrome (PDS). The purpose of the study was to analyze perioperative, functional, and radiological data between the two techniques.

METHODS A retrospective analysis of patient data was performed between 2015 and 2018. Patients were clustered into two homogeneous groups (group 1 = ALIF, group 2 = TLIF) according to surgical procedure. A statistical analysis of clinical perioperative and radiological findings was performed to compare the two groups. A senior musculoskeletal radiologist retrospectively revised all radiological images.

RESULTS Seventy-two patients were comparable in terms of demographic features and surgical diagnosis and included in the study, involving 32 (44.4%) male and 40 (55.6%) female patients with an average age of 47.7 years. The mean follow-up duration was 49.7 months. Thirty-six patients (50%) were clustered in group 1, including 31 (86%) with DDD and 5 (14%) with PDS. Thirty-six patients (50%) were clustered in group 2, including 28 (78%) with DDD and 8 (22%) with PDS. A significant reduction in surgical time (107.4 vs 181.1 minutes) and blood loss (188.9 vs 387.1 ml) in group 1 (p < 0.0001) was observed. No significant differences in complications and reoperation rates between the two groups (p = 0.561) was observed. A significant improvement in functional outcome was observed in both groups (p < 0.001), but no significant difference between the two groups was found at the last follow-up. In group 1, a faster median time of return to work (2.4 vs 3.2 months) was recorded. A significant improvement in L5–S1 postoperative lordosis restoration was registered in the ALIF group (9.0 vs 5.0, p = 0.023).

CONCLUSIONS According to these results, interbody fusion is effective in the surgical management of discogenic pain. Even if clinical benefits were achieved earlier in the ALIF group (better scores and faster return to work), both procedures improved functional outcomes at last follow-up. The ALIF group showed significant reduction of blood loss, shorter surgical time, and better segmental lordosis restoration when compared to the TLIF group. No significant differences in postoperative complications were observed between the groups. Based on these results, the ALIF technique enhances radiological outcome improvement in spinopelvic parameters when compared to TLIF in the management of adult patients with L5–S1 DDD.

Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study

J Neurosurg Spine 31:347–356, 2019

Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics’ Maverick total disc replacement.

METHODS Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.

RESULTS Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.

CONCLUSIONS Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.

Clinical trial registration no.: NCT00635843 (clinicaltrials.gov)

 

The ‘Lumbar Fusion Outcome Score’ (LUFOS): a new practical and surgically oriented grading system for preoperative prediction of surgical outcomes after lumbar spinal fusion in patients with degenerative disc disease and refractory chronic axial low back pain

Neurosurg Review (40) pp 67–81, 2017

In order to evaluate the predictive effect of non-invasive preoperative imaging methods on surgical outcomes of lumbar fusion for patients with degenerative disc disease (DDD) and refractory chronic axial low back pain (LBP), the authors conducted a retrospective review of 45 patients with DDD and refractory LBP submitted to anterior lumbar interbody fusion (ALIF) at a single center from 2007 to 2010.

Surgical outcomes – as measured by Visual Analog Scale (VAS/back pain) and Oswestry Disability Index (ODI) – were evaluated pre-operatively and at 6 weeks, 3 months, 6 months, and 1 year post-operatively. Linear mixed-effects models were generated in order to identify possible preoperative imaging characteristics (including bone scan/99mTc scintigraphy increased endplate uptake, Modic endplate changes, and disc degeneration graded according to Pfirrmann classification) which may be predictive of long-term surgical outcomes .

After controlling for confounders, a combined score, the Lumbar Fusion Outcome Score (LUFOS), was developed. The LUFOS grading system was able to stratify patients in two general groups (Non-surgical: LUFOS 0 and 1; Surgical: LUFOS 2 and 3) that presented significantly different surgical outcomes in terms of estimated marginal means of VAS/back pain (p = 0.001) and ODI (p = 0.006) beginning at 3 months and continuing up to 1 year of follow-up.

In conclusion, LUFOS has been devised as a new practical and surgically oriented grading system based on simple key parameters from non-invasive preoperative imaging exams (magnetic resonance imaging/MRI and bone scan/99mTc scintigraphy) which has been shown to be highly predictive of surgical outcomes of patients undergoing lumbar fusion for treatment for refractory chronic axial LBP.

Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses

activ-c-xray

J Neurosurg Spine 25:556–565, 2016

Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis.

Methods A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis.

Results Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from -2.4° preoperatively to -6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment.

Conclusions The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR.

Validity and Reliability of a Measurement of Objective Functional Impairment in Lumbar Degenerative Disc Disease: The Timed Up and Go (TUG) Test

Validity and Reliability of a Measurement of Objective Functional Impairment in Lumbar Degenerative Disc Disease- The Timed Up and Go (TUG) Test

Neurosurgery 79:270–278, 2016

There are few objective measures of functional impairment to support clinical decision making in lumbar degenerative disc disease (DDD).

OBJECTIVE: We present the validation (and reliability measures) of the Timed Up and Go (TUG) test.

METHODS: In a prospective, 2-center study, 253 consecutive patients were assessed using the TUG test. A representative cohort of 110 volunteers served as control subjects. The TUG test values were assessed for validity and reliability.

RESULTS: The TUG test had excellent intra- (intraclass correlation coefficient: 0.97) and interrater reliability (intraclass correlation coefficient: 0.99), with a standard error of measurement of 0.21 and 0.23 seconds, respectively. The validity of the TUG test was demonstrated by a good correlation with the Visual Analog Scale (VAS) back (Pearson’s correlation coefficient [PCC]: 0.25) and VAS (PCC: 0.29) leg pain, functional impairment (Roland-Morris Disability Index [PCC: 0.38] and Oswestry Disability Index [PCC: 0.34]), as well as with health-related quality of life (Short Form-12 Mental Component Summary score [PCC: 20.25], Short Form-12 Physical Component Summary score [PCC: 20.32], and EQ-5D [PCC: 20.28]). The upper limit of “normal” was 11.52 seconds. Mild (lower than the 33rd percentile), moderate (33rd to 66th percentiles), and severe objective functional impairment (higher than the 66th percentile) as determined by the TUG test was <13.4 seconds, 13.4 to 18.4 seconds, and >18.4 seconds, respectively.

CONCLUSION: The TUG test is a quick, easy-to-use, valid, and reliable tool to evaluate objective functional impairment in patients with lumbar degenerative disc disease. In the clinical setting, patients scoring a TUG test time of over 12 seconds can be considered to have functional impairment.

Lumbar Total Disc Replacement for Discogenic Low Back Pain

Lumbar Total Disc Replacement for Discogenic Low Back Pain

Spine 2015;40:1873–1881

A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.

Objective. The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy.

Summary of Background Data. Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR.

Methods. Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational TDR device (activL1, n=218) or FDA-approved control TDR devices (ProDisc-L or Charité, n=106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls.

Results. The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P<0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P=0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P<0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P=0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P=0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%).

Conclusion. The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years.

Level of Evidence: 2

Classification of degenerative segment disease in adults with deformity of the lumbar or thoracolumbar spine

Classification of degenerative segment disease in adults with deformity of the lumbar or thoracolumbar spine

Eur Spine J (2014) 23:1815–1824

Lumbar and thoracolumbar deformity in the adult is a condition with impairment of health status that can need surgical treatment. In contrast with adolescent deformity, where magnitude of the curve plays a significant role in surgical indication, the aspects relevant in adult deformity are pain and dysfunction that correlate with segment degeneration and imbalance. Previous classifications of adult deformity have been of little use for surgical planning.

Methods Chart review and classification of radiographic and clinical findings. A classification of degenerative disc disease based on distribution of diseased segments and balance status of the spine is presented.

Results Four main categories are presented: Type I (limited nonapical segment disease), Type II (limited apical segment disease), Type III (extended segment disease— apical and nonapical), Type IV (imbalanced spine: IVa, sagittally imbalanced; IVb, sagittally and coronally imbalanced).

Discussion and conclusion Types I and II can be treated by fusion of a selective area of the curve. Type III needs fusion of all the extension of the coronal curve. Type IV usually needs aggressive corrective procedures, frequently including posterior tricolumnar osteotomies. This classification permits interpreting the extension and magnitude of the disease and can help establish a surgical plan regarding selective fusion and methods of sagittal correction. Future research is needed to validate the classification.

Back pain in patients with degenerative spine disease and intradural spinal tumor: what to treat? when to treat?

Intradural tumorEur Spine J (2014) 23:821–829

Back pain is common in industrialized countries and one of the most frequent causes of work incapacity. Successful treatment is, therefore, not only important for improving the symptoms and the quality of life of these patients but also for socioeconomic reasons. Back pain is frequently caused by degenerative spine disease. Intradural spinal tumors are rare with an annual incidence of 2–4/1,00,000 and are mostly associated with neurological deficits and radicular and nocturnal pain. Back pain is not commonly described as a concomitant symptom, such that in patients with both a tumor and degenerative spine disease, any back pain is typically attributed to the degeneration rather than the tumor.

Objective The aim of the present retrospective investigation was to study and analyze the impact of microsurgery on back/neck pain in patients with intradural spinal tumor in the presence of degenerative spinal disease in adjacent spinal segments.

Methods Fifty-eight consecutive patients underwent microsurgical, intradural tumor surgery using a standardized protocol assisted by multimodal intraoperative neuromonitoring. Clinical symptoms, complications and surgery characteristics were documented. Standardized questionnaires were used to measure outcome from the surgeon’s and the patient’s perspectives (Spine Tango Registry and Core Outcome Measures Index). Follow-up included clinical and neuroradiological examinations 6 weeks, 3 months and 1 year postoperatively.

Results Back/neck pain as a leading symptom and coexisting degenerative spine disease was present in 27/58 (47 %) of the tumor patients, and these comprised to group under study. Patients underwent tumor surgery only, without addressing the degenerative spinal disease. Remission rate after tumor removal was 85 %. There were no major surgical complications. Back/neck pain as the leading symptom was eradicated in 67 % of patients. There were 7 % of patients who required further invasive therapy for their degenerative spinal disease.

Conclusions Intradural spinal tumor surgery improves back/neck pain in patients with coexisting severe degenerative spinal disease. Intradural spinal tumors seem to be the only cause of back/neck pain more often than appreciated. In these patients suffering from both pathologies, there is a higher risk of surgical overtreatment than undertreatment. Therefore, elaborate clinical and radiological examinations should be performed preoperatively and the indication for stabilization/fusion should be discussed carefully in patients foreseen for first time intradural tumor surgery.

 

Schmorl’s nodes: current pathophysiological, diagnostic, and therapeutic paradigms

Schmorl's nodes

Neurosurg Rev (2014) 37:39–46

Schmorl’s nodes were first described by the pathologist Christian Schmorl in 1927 as a herniation of the nucleus pulposus through the cartilaginous and bony endplate into the vertebral body. Although such lesions present most commonly as incidental findings in asymptomatic patients (or in patients with back or radicular pain due to other etiology), there have been several reports emphasizing the deleterious effects of the inflammatory response and endplate changes elicited by the herniation of for such reasons, Schmorl’s nodes have been occasionally implicated in the etiology of chronic axial pain as well as in pathological osteoporotic fractures.

In this article, a thorough literature review about the most relevant historical studies on Schmorl’s nodes previously published is performed. Furthermore, the authors provide an overview about the recent advances in basic science research on the pathophysiology of such lesions, as well as on current diagnostic and therapeutic paradigms.

Differences between 1- and 2-level cervical arthroplasty

J Neurosurg Spine 16:594–600, 2012. (http://thejns.org/doi/abs/10.3171/2012.2.SPINE111066)

The most currently accepted indication for cervical arthroplasty is 1- or 2-level degenerative disc disease (DDD) refractory to medical treatment. However, the randomized and controlled clinical trials by the US FDA investigational device exemption studies only compared cervical arthroplasty with anterior cervical discectomy and fusion for 1-level disease. Theoretically, 2-level cervical spondylosis usually implicates more advanced degeneration, whereas the 1-level DDD can be caused by merely a soft-disc herniation. This study aimed to investigate the differences between 1- and 2-level cervical arthroplasty.

Methods. The authors analyzed data obtained in 87 consecutive patients who underwent 1- or 2-level cervical arthroplasty with Bryan disc. The patients were divided into the 1-level and the 2-level treatment groups. Clinical outcomes were measured using the visual analog scale (VAS) for the neck and arm pain and the Neck Disability Index (NDI), with a minimum follow-up of 30 months. Radiographic outcomes were evaluated on both radiographs and CT scans.

Results. The study analyzed 98 levels of Bryan cervical arthroplasty in 70 patients (80.5%) who completed the evaluations in a mean follow-up period of 46.21 ± 9.85 months. There were 22 females (31.4%) and 48 males (68.6%), whose mean age was 46.57 ± 10.07 years at the time of surgery. The 1-level group had 42 patients (60.0%), while the 2-level group had 28 patients (40.0%). Patients in the 1-level group were younger than those in the 2-level group (mean 45.00 vs 48.93 years, p = 0.111 [not significant]). Proportional sex compositions and perioperative prescription of nonsteroidal antiinflammatory drugs were also similar in both groups (p = 0.227 and p = 1.000). The 2-level group had significantly greater EBL during surgery than the 1-level group (220.80 vs 111.89 ml, p = 0.024). Heterotopic ossification was identified more frequently in the 2-level group than the 1-level group (75.0% vs 40.5%, p = 0.009). Although most of the artificial discs remained mobile during the follow up, the 2-level group had fewer mobile discs (100% and 85.7%, p = 0.022) than the 1-level group. However, in both groups, the clinical outcomes measured by VAS for neck pain, VAS for arm pain, and NDI all significantly improved after surgery compared with that preoperatively, and there were no significant differences between the groups at any point of evaluation (that is, at 3, 6, 12, and 24 months after surgery).

Conclusions. Clinical outcomes of 1- and 2-level cervical arthroplasty were similar at 46 months after surgery, and patients in both groups had significantly improved compared with preoperative status. However, there was a significantly higher rate of heterotopic ossification formation and less mobility of the Bryan disc in patients who underwent 2-level arthroplasty. Although mobility to date has been maintained in the vast majority (94.3%) of patients, the long-term effects of heterotopic ossification warrant further investigation.

Analysis of three IDE cervical arthroplasty trials

J Neurosurg Spine 16:216–228, 2012. DOI: 10.3171/2011.6.SPINE10623

There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials.

Methods. A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models.

Results. The authors’ analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis.

Conclusions. Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.

Overview of disc arthroplasty—past, present and future

DOI:10.1007/s00701-009-0529-5. Acta Neurochirugica

Degenerative disc disease is one of the most frequent spinal disorders. The anatomy and the biomechanics of the intervertebral disc are very complex, and the pathomechanics of its degeneration are poorly understood. Despite this complexity and uncertainty, great advances have been made in the field of disc replacement technology, with promising results. Difficulties are continuously being encountered, but careful analysis of the results and intensive research and development will assist in countering these problems. There are approximately 40 clinical reports in the literature describing various aspects of randomised controlled trials involving intervertebral disc arthroplasty. However, the majority of these publications do not provide reliable information, in that they give only interim results and/or the results from just one of the many centres in multicentre studies. Such publications must be interpreted with caution, since they do not always represent the results of the whole study population and may hence be underpowered. We identified six randomised controlled trials that compared the final clinical outcomes of disc arthroplasty and spinal fusion. The present systematic review attempts to give an overview of the current status of disc arthroplasty.

Overview of disc arthroplasty—past, present and future

Acta Neurochir (2010) 152:393–404. DOI 10.1007/s00701-009-0529-5

Degenerative disc disease is one of the most frequent spinal disorders. The anatomy and the biomechanics of the intervertebral disc are very complex, and the pathomechanics of its degeneration are poorly understood. Despite this complexity and uncertainty, great advances have been made in the field of disc replacement technology, with promising results. Difficulties are continuously being encountered, but careful analysis of the results and intensive research and development will assist in countering these problems. There are approximately 40 clinical reports in the literature describing various aspects of randomised controlled trials involving intervertebral disc arthroplasty. However, the majority of these publications do not provide reliable information, in that they give only interim results and/or the results from just one of the many centres in multicentre studies. Such publications must be interpreted with caution, since they do not always represent the results of the whole study population and may hence be underpowered. We identified six randomised controlled trials that compared the final clinical outcomes of disc arthroplasty and spinal fusion. The present systematic review attempts to give an overview of the current status of disc arthroplasty.