Study Design Retrospective cohort study. Objectives Odontoid fractures are the most common cervical spine fractures in the elderly. The optimal treatment remains controversial. The aim of this... Show moreStudy Design Retrospective cohort study. Objectives Odontoid fractures are the most common cervical spine fractures in the elderly. The optimal treatment remains controversial. The aim of this study was to compare results of a low-threshold-for-surgery strategy (surgery for dislocated fractures in relatively healthy patients) to a primarily-conservative strategy (for all patients). Methods Patient records from 5 medical centers were reviewed for patients who met the selection criteria (e.g. age & GE;55 years, type II/III odontoid fractures). Demographics, fracture types/characteristics, fracture union/stability, clinical outcome and mortality were compared. The influence of age on outcome was studied (& GE;55-80 vs & GE;80 years). Results A total of 173 patients were included: 120 treated with low-threshold-for-surgery (of which 22 primarily operated, and 23 secondarily) vs 53 treated primarily-conservative. No differences in demographics and fracture characteristics between the groups were identified. Fracture union (53% vs 43%) and fracture stability (90% vs 85%) at last follow-up did not differ between groups. The majority of patients (56%) achieved clinical improvement compared to baseline. Analysis of differences in clinical outcome between groups was infeasible due to data limitations. In both strategies, patients & GE;80 years achieved worse union (64% vs 30%), worse stability (97% vs 77%), and - as to be expected - increased mortality <104 weeks (2% vs 22%). Conclusions Union and stability rates did not differ between the treatment strategies. Advanced age (& GE;80 years) negatively influenced both radiological outcome and mortality. No cases of secondary neurological deficits were identified, suggesting that concerns for the consequences of under-treatment may be unjustified. Show less
Suasnabar, J.M.H.; Vleggeert-Lankamp, C.L.A.; Goedmakers, C.M.W.; Vries, F. de; Arts, M.P.; Akker-van van den 2023
BACKGROUND CONTEXT: In the treatment of cervical radiculopathy due to a herniated disc, potential surgical treatments include: anterior cervical discectomy (ACD), ACD and fusion using a cage (ACDF)... Show moreBACKGROUND CONTEXT: In the treatment of cervical radiculopathy due to a herniated disc, potential surgical treatments include: anterior cervical discectomy (ACD), ACD and fusion using a cage (ACDF), and anterior cervical disc arthroplasty (ACDA). Previous publications yielded com-parable clinical and radiological outcome data for the various implants, but research on their com-parative costutility has been inconclusive.PURPOSE: To evaluate the cost utility of ACD, ACDF, and ACDA.STUDY DESIGN: Cost-utility analysis.PATIENT SAMPLE: About 109 patients with cervical radiculopathy randomized to undergo ACD, ACDF, or ACDA as part of the NEtherlands Cervical Kinetics trial.OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated from patient-reported utilities using the EuroQol-5D questionnaire and EuroQol Visual Analogue Scale (EQ VAS), mea-sured at baseline, 2, 4, 8, 12, 26, 52, and 104 weeks postprocedure. Societal costs including admis-sions to hospital (related and otherwise), GP visits, specialist visits, physical therapy, medications, home care, aids, informal care, productivity losses, and out of pocket condition-related expenses.METHODS: The cost utility of the competing strategies over 1 and 2 years was assessed following a net benefit (NB) approach, whereby the intervention with the highest NB among competing strat-egies is preferred. Cost effectiveness acceptability curves were produced to reflect the probability of each strategy being the most cost effective across various willingness-to-pay (WTP) thresholds. Five sensitivity analyses were conducted to assess the robustness of results. RESULTS: ACDF was more likely to be the most cost-effective strategy at WTP thresholds of euro20,000 to 50,000/QALY in all but one of the analyses. The mean QALYs during the first year were 0.750, 0.817, and 0.807 for ACD, ACDF, and ACDA, respectively, with no significant differ-ences between groups. Total healthcare costs over the first year were significantly higher for ACDA, largely due to the higher surgery and implant costs. The total societal costs of the three strategies were euro12,173 for ACD, euro11,195 for ACDF, and euro13,746 for ACDA, with no significant differences between groups.CONCLUSION: Our findings demonstrate that ACDF is likely to be more cost-effective than ACDA or ACD at most WTP thresholds, and this conclusion is robust to most sensitivity analyses conducted. It is demonstrated that the difference in costs is mainly caused by the initial surgical costs and that there are only minimal differences in other costs during follow-up. Since clinical data are comparable between the groups, it is to the judgment of the patient and surgeon which intervention is applied. (c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) Show less
OBJECTIVE In the surgical treatment of isthmic spondylolisthesis, it is debatable whether instrumented fusion is mandatory in addition to decompression. The objective of this prospective cohort... Show moreOBJECTIVE In the surgical treatment of isthmic spondylolisthesis, it is debatable whether instrumented fusion is mandatory in addition to decompression. The objective of this prospective cohort study was to assess the long-term effect of decompression alone compared with decompression and instrumented fusion in patients who underwent the intervention of their own preference. The results were compared with those in patients who underwent randomly assigned treatment.METHODS The authors performed a prospective observational multicenter cohort study, including 91 patients with isthmic spondylolisthesis assigned to undergo either decompression alone (n = 44) or decompression and fusion (n = 47). The main outcomes were the Roland-Morris Disability Questionnaire (RDQ) scores and the patient's perceived recovery at the 2-year follow-up. Secondary outcomes were visual analog scale (VAS) leg pain and back pain scores and the reoperation rate. A meta-analysis was performed for data from this cohort study (n = 91) and from a randomized controlled trial (RCT) previously reported by the authors (n = 84). Subgroup analyses were performed on these combined data for age, sex, weight, smoking, and Meyerding grade.RESULTS At the 12-week follow-up, improvements of RDQ scores were comparable for the two procedures (decompression alone [D group] 4.4, 95% CI 2.3-6.5; decompression and fusion [DF group] 5.8, 95% CI -4.3 to 1.4; p = 0.31). Likewise, VAS leg pain scores (D group 35.0, 95% CI 24.5-45.6; DF group 47.5, 95% CI 37.4-57.5; p = 0.09) and VAS back pain scores (D group 23.5, 95% CI 13.3-33.7; DF group 34.0, 95% CI 24.1-43.8; p = 0.15) were comparable. At the 2-year follow-up, there were no significant differences between the two groups in terms of scores for RDQ (difference -3.1, 95% CI -6.4 to 0.3, p = 0.07), VAS leg pain (difference -7.4, 95% CI -22.1 to 7.2, p = 0.31), and VAS back pain (difference -11.4, 95% CI -25.7 to 2.9, p = 0.12). In contrast, patient-perceived recovery from leg pain was significantly higher in the DF group (79% vs 51%, p = 0.02). Subgroup analyses did not demonstrate a superior outcome for decompression alone compared with decompression and fusion. Nine patients (20.5%) underwent reoperation in total, all in the D group. The meta-analysis including both the cohort and RCT populations yielded an estimated pooled mean difference in RDQ of -3.7 (95% CI -5.94 to -1.55, p = 0.0008) in favor of decompression and fusion at the 2-year follow- up.CONCLUSIONS In patients with isthmic spondylolisthesis, at the 2-year follow-up, patients who underwent decompression and fusion showed superior functional outcome and perceived recovery compared with those who underwent decompression alone. No subgroups benefited from decompression alone. Therefore, decompression and fusion is recommended over decompression alone as a primary surgical treatment option in isthmic spondylolisthesis. Show less
BACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment dis-ease as compared... Show moreBACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment dis-ease as compared to anterior cervical discectomy and fusion (ACDF). PURPOSE: To evaluate the long-term outcome in patients with cervical radiculopathy due to a herniated disc undergoing ACDA, ACDF or ACD (no cage, no plate) in terms of clinical outcome measured by the Neck Disability Index (NDI). Likewise, clinically relevant adjacent segment dis-ease is assessed as a long-term result. STUDY DESIGN: Double-blinded randomized controlled trial.PATIENT SAMPLE: A total of 109 patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without cage.OUTCOME MEASURES: Clinical outcome was measured by patients' self-reported NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, perceived recovery and reopera-tion rate. Radiological outcome was assessed by radiographic cervical curvature and adjacent seg-ment degeneration (ASD) parameters at baseline and up until five years after surgery.METHODS: To account for the correlation between repeated measurements of the same individ-ual Generalized Estimated Equations (GEE) were used to calculate treatment effects, expressed in difference in marginal mean values for NDI per treatment group. RESULTS: Clinical outcome parameters were comparable in the ACDA and ACDF group, but significantly worse in the ACD group, though not reaching clinical relevance. Annual reoperation rate was 3.6% in the first two years after surgery, declined to 1.9% in the years thereafter. The num-ber of reoperations for ASD was not lower in the ACDA group, while the number of reoperations at the index level was higher after ACD, when compared to ACDF and ACDA.CONCLUSIONS: A persisting absence of clinical superiority was demonstrated for the cervical disc prosthesis five years after surgery. Specifically, clinically relevant adjacent level disease was not prevented by implanting a prosthesis. Single level ACD without implanting an intervertebral device provided worse clinical outcome, which was hypothesized to be caused by delayed fusion. This stresses the need for focusing on timely fusion in future research.(c) 2022 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) Show less
Background: A spinal epidural abscess (SEA) of the cervical spine is a relatively rare disease and is generally characterized by progressive neurological deterioration due to compression of the... Show moreBackground: A spinal epidural abscess (SEA) of the cervical spine is a relatively rare disease and is generally characterized by progressive neurological deterioration due to compression of the spinal cord. Up to 40% of cervical SEAs are located ventrally of the spinal cord. Urgent surgical intervention is warranted to decompress the spinal cord and collect material for cultures to guide antibiotic treatment. However, the optimal timing of the intervention is unclear, and the associated risk of spinal instability in the presence of an extensive infection is a significant clinical dilemma. Methods: In this paper, we present a novel surgical technique to treat a cervical SEA by anterior decompression through a linear transvertebral midline approach. This technique has the advantage of effectively draining the ventrally located SEA and obtaining material for bacteria culture while maintaining spinal stability without additional instrumentation. Results: This case study presents seven patients with cervical SEAs who were successfully treated with surgical decompression by this transvertebral linear midline technique and antibiotic treatment. Conclusion: Anterior decompression through a linear transvertebral midline approach for a ventrally located cervical SEA is a safe and pragmatic surgical procedure to achieve spinal cord decompression and collect bacteria culture without destabilizing the cervical spine. Show less
Background Depression and anxiety are common mental disorders among patients with chronic pain. It is hypothesised that patients suffering from these disorders benefit less from cervical spine... Show moreBackground Depression and anxiety are common mental disorders among patients with chronic pain. It is hypothesised that patients suffering from these disorders benefit less from cervical spine surgery than mentally healthy patients. Therefore, this study aimed to quantify the effect of mental health status on functional outcome after anterior cervical discectomy in a post hoc analysis on RCT data. Methods One hundred eight patients from the NECK trial, with radiculopathy due to a one-level herniated disc, underwent anterior cervical discectomy and were included into this analysis. Functional outcome was quantified using the Neck Disability Index (NDI), and mental health status was measured using the Hospital Anxiety and Depression Score (HADS) questionnaire. NDI differences were assessed using generalised estimated equations (GEE), crude means, a predictive linear mixed model (LMM) using baseline scores and over time with an explanatory LMM. Results At baseline, 24% and 32% of patients were respectively depressed and anxious and had statistically significant and clinically relevant higher NDI scores during follow-up. However, in those patients in which the HADS returned to normal during follow-up, NDI values decreased comparably to the non-depression or non-anxiety cases. Those patients that demonstrated persisting high HADS values had convincingly worse NDI scores. A predictive LMM showed that combining baseline NDI and HADS scores was highly predictive of NDI during follow-up. The R shiny application enabled the effective, visual communication of results from the predictive LMM. Conclusion This study shows that mental health status and disability are strongly associated and provides insight into the size of the effect, as well as a way to use this relation to improve preoperative patient counselling. These findings give rise to the suggestion that incorporating mental health screening in the preoperative assessment of patients could help to adequately manage patients' expectations for functional recovery. Show less
OBJECTIVE: Interspinous process distraction devices (IPDs) can be implanted to treat patients with intermittent neurogenic claudication (INC) due to lumbar spinal stenosis. Short-term results... Show moreOBJECTIVE: Interspinous process distraction devices (IPDs) can be implanted to treat patients with intermittent neurogenic claudication (INC) due to lumbar spinal stenosis. Short-term results provided evidence that the outcomes of IPD implantation were comparable to those of decompressive surgery, although the reoperation rate was higher in patients who received an IPD. This study focuses on the long-term results. METHODS: Patients with INC and spinal stenosis at 1 or 2 levels randomly underwent either decompression or IPD implantation. Patients were blinded to the allocated treatment. The primary outcome was the Zurich Claudication Questionnaire (ZCQ) score at 5-year follow-up. Repeated measurement analysis was applied to compare outcomes over time. RESULTS: In total, 159 patients were included and randomly underwent treatment: 80 patients were randomly assigned to undergo IPD implantation, and 79 underwent spinal bony decompression. At 5 years, the success rates in terms of ZCQ score were similar (68% of patients who underwent IPD implantation had a successful recovery vs 56% of those who underwent bony decompression, p = 0.422). The reoperation rate at 2 years after surgery was substantial in the IPD group (29%), but no reoperations were performed thereafter. Long-term visual analog scale score for back pain was lower in the IPD group than the bony decompression group (p = 0.02). CONCLUSIONS: IPD implantation is a more expensive alternative to decompressive surgery for INC but has comparable functional outcome during follow-up. The risk of reoperation due to absence of recovery is substantial in the first 2 years after IPD implantation, but if surgery is successful this positive effect remains throughout long-term follow-up. The IPD group had less back pain during long-term follow-up, but the clinical relevance of this finding is debatable. Dutch Trial Register no.: NTR1307 https://thejns.org/doi/abs/10.3171/2021.8.SPINE21419 Show less
Study Design. Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical... Show moreStudy Design. Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical discectomy and arthroplasty (ACDA) to anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy (ACD), for single-level disc herniation. Objective. This study aimed to investigate whether the ACDA procedure offers superior clinical results 2 years after surgery, to either ACDF or ACD without instrumentation, in the entire group of patients or in a particular subgroup of patients. Summary of Background Data. The cervical disc prosthesis was introduced to provide superior clinical outcomes after ACD. Methods. Neck Disability Index (NDI), and subscales of the 36-item short-form health survey (SF-36) and McGill pain score were collected at baseline, 1 year and 2 years after surgery. Reoperations and complications were also evaluated. A preliminary subgroup analysis was performed for age, disc height, body mass index (BMI), smoking, and sex. Results. The NDI decreased comparably in all treatment arms to circa 50% of the baseline value and marginal mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with confidence intervals never exceeding the 20-point minimal clinical important difference (MCID). Secondary outcome parameters showed comparable results. Preliminary subgroup analysis could not demonstrate clinically relevant differences in NDI between treatments after 2 years. Conclusion. After combining data from two Randomized Controlled Trials it can be concluded that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. Preliminary subgroup analysis indicated outcomes were similar between treatment groups, and that no subgroup could be appointed that benefited more from either ACD, ACDF, or ACDA. Show less
OBJECTIVE The most advocated surgical technique to treat symptoms of isthmic spondylolisthesis is decompression with instrumented fusion. A less-invasive classical approach has also been reported,... Show moreOBJECTIVE The most advocated surgical technique to treat symptoms of isthmic spondylolisthesis is decompression with instrumented fusion. A less-invasive classical approach has also been reported, which consists of decompression only. In this study the authors compared the clinical outcomes of decompression only with those of decompression with instrumented fusion in patients with isthmic spondylolisthesis. METHODS Eighty-four patients with lumbar radiculopathy or neurogenic claudication secondary to low-grade isthmic spondylolisthesis were randomly assigned to decompression only (n = 43) or decompression with instrumented fusion (n = 41). Primary outcome parameters were scores on the Roland Disability Questionnaire (RDQ), separate visual analog scales (VASs) for back pain and leg pain, and patient report of perceived recovery at 12-week and 2-year follow-ups. The proportion of reoperations was scored as a secondary outcome measure. Repeated measures ANOVA according to the intention-to-treat principle was performed. RESULTS Decompression alone did not show superiority in terms of disability scores at 12-week follow-up (p = 0.32, 95% CI -4.02 to 1.34), nor in any other outcome measure. At 2-year follow-up, RDQ disability scores improved more in the fusion group (10.3, 95% CI 3.9-8.2, vs 6.0, 95% CI 8.2-12.4; p = 0.006, 95% CI -7.3 to -1.3). Likewise, back pain decreased more in the fusion group (difference: -18.3 mm, CI -32.1 to -4.4, p = 0.01) on a 100-mm VAS scale, and a higher proportion of patients perceived recovery as showing "good results" (44% vs 74%, p = 0.01). Cumulative probabilities for reoperation were 47% in the decompression and 13% in the fusion group (p < 0.001) at the 2-year follow-up. CONCLUSIONS In patients with isthmic spondylolisthesis, decompression with instrumented fusion resulted in comparable short-term results, significantly better long-term outcomes, and fewer reoperations than decompression alone. Decompression with instrumented fusion is a superior surgical technique that should in general be offered as a first treatment option for isthmic spondylolisthesis, but not for degenerative spondylolisthesis, which has a different etiology. Clinical trial registration number: NTR1300 (Netherlands Trial Register) Show less
Study Design. Retrospective analysis using data from randomized clinical trials.Objective. To compare the occurrence of heterotopic ossification ( HO) between two cervical disc prostheses. Clinical... Show moreStudy Design. Retrospective analysis using data from randomized clinical trials.Objective. To compare the occurrence of heterotopic ossification ( HO) between two cervical disc prostheses. Clinical outcome and range of motion (ROM) were also evaluated.Summary of Background Data. Cervical arthroplasty was reported to be able to maintain the segmental ROM. However, controversy exists since the difference of the occurrence of HO concerning cervical prosthesis is still huge.Methods. Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy due to a herniated disc from the The Netherlands Cervical Kinematics (NECK) trial (activC; metal endplates with a polyethylene inlay and a keel for primary stability) and the PROCON trial (Bryan; metal-on-polymer with titanium coated endplates without a keel) were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee- Mehren classification. Segmental ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the neck disability index (NDI) as well as physicalcomponent summary (PCS) and mental-component summary (MCS).Results. At 2-year follow-up, the occurrence of HO was 68% in patients treated with the activC prosthesis (severe HO 55%), which was comparable with 85% (P = 0.12) in patients with the Bryan disc (severe HO 44%; P = 0.43). The HO progression was similar between groups. Clinically, the patients had comparable NDI, PCS, and MCS at 2-year follow-up, and comparable improvement of clinical outcomes. The global ROM in the Bryan group (56.4 +/- 10.8 degrees) was significantly higher than in the activC group (49.5 +/- 14.0, P = 0.044) at 2-year follow-up.Conclusion. In comparison of two cervical disc prostheses the development of HO is independent on their architecture. Although global ROM was higher in the Bryan prosthesis group, this difference was not deemed clinically important, particularly because the clinical condition of patients with and without severe HO was comparable. Show less
Study Design. Retrospective analysis using data from RCTs.Objective. This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical... Show moreStudy Design. Retrospective analysis using data from RCTs.Objective. This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis.Summary of Background Data. Cervical disc prostheses were introduced to prevent ASD in the postsurgical follow-up. However, it is still a controversial issue.Methods. Two hundred fifty-three patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level.Results. Radiological ASD was present in 34% of patients at baseline and increased to 59% at 2-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.Conclusion. Radiological ASD occurs in a similar manner in patients who were subjected to arthrodesis in cervical radiculopathy and in patients who received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent. Show less
