Eubulus J. Kerr

Delayed hyper-reactivity to metal ions after cervical disc arthroplasty: a case report and literature review.

Study Design. Anecdotal case report. Objective. To report a very interesting and perplexing complication of cervical total disc arthroplasty that has not been previously reported in literature. Summary of Background Data. Although there has been increasing interest in the field of artificial disc replacement to treat cervical degenerative disc disease, not much has been mentioned in the literature about the potential complications of the disc itself. We encountered a delayed complication in 1 patient that has not been reported in the literature. Method. Thirty-nine-year-old white woman received total disc arthroplasty for herniated intervertebral disc at C5–C6 level uneventfully. She had recurrence of symptoms 9 months after the procedure and failed to respond to conservative measurements. Imaging revealed soft tissue mass posterior to the implanted disc encroaching the spinal cord. Results. Surgical explantation and exploration of the disc space revealed thick layer of abnormal hyaline cartilaginous tissue with chronic inflammatory debris. The patient had complete resolution of symptoms after the revision surgery. Conclusion. Although there is increased enthusiasm about motion preservation technology and disc replacement surgery for intervertebral disc herniation, unexpected complications like the present case need to be shared within the scientific community to better understand the risks associated with these new and promising devices.

Factors affecting the incidence of symptomatic adjacent-level disease in cervical spine after total disc arthroplasty: 2- to 4-year follow-up of 3 prospective randomized trials.

Study Design. Prospective randomized clinical trials. Objective. To compare the outcome data with respect to clinical success rates and incidence of adjacent level disease (ALD) in patients after total disc arthroplasty (TDA) or anterior cervical fusion (ACDF) for 1- and 2-level cervical disc disease. Summary of Background Data. Previously published studies have provided evidence that ACDF procedure for cervical degenerative disc disease (DDD) may increase the stress on the nonoperated adjacent cervical segments, thus possibly increasing the risk of degeneration at these levels. The theoretical assumption that TDA may reduce the incidence of future ALD by preserving motion at the affected segments has, however, never been validated by clinical evidence. Methods. One hundred seventy patients with established symptomatic cervical disc disease at 1 or 2 levels participated in 3 prospective randomized clinical trials at 2 institutions. Participating subjects were randomized to receive TDA (treatment; n = 113) or ACDF (control; n = 57) by 6 independent investigating surgeons. Visual analogue pain scores (0–100), Neck Disability Index, neurological examination, and cervical spine radiographs were collected at enrollment and then 6 weeks and 3, 6, 12, 24, 36, and 48 months after surgery. Patients with persistent symptoms during the follow-up period were investigated for adjacent segment disease (ASD) with computed tomography/magnetic resonance imaging of the cervical spine, neurophysiology, and subsequent active interventions. Results. At the median follow-up of 42 months (range: 28–54 months), 9 (14.3%) ACDF and 19 (16.8%) TDA patients developed and were actively treated for ASD. Osteopenia dust energy x-ray absorptiometry T scores of −1.5 to −2.4) (P = 0.04; 95% confidence interval [CI]: 0.007–0.223) and concurrent lumbar degenerative disease (P = 0.02; 95% CI: 0.003–0.196) significantly increased the risk of ASD. Conclusion. The risk of developing adjacent segment degeneration was equivalent at median 38 months after both ACDF and TDA procedures in cervical DDD. Osteopenia and concurrent lumbar DDD significantly increase the risk of ALD.

Choice of plate may affect outcomes for single versus multilevel ACDF: results of a prospective randomized single-blind trial

BACKGROUND CONTEXT Conflicting views exist according to the individual philosophy about various plate designs that can be used in anterior cervical discectomy and fusion (ACDF) to achieve clinical and radiological improvement within shortest time period. No prospective randomized study has ever been conducted to clarify the relationship between clinical outcomes, fusion rates, and the choice of plate (static vs. dynamic design). PURPOSE To compare the clinical and radiological outcomes of patients treated with one-level or multiple levels ACDF using cervical plates of dynamic (slotted-holes) versus static (fixed-holes) design. STUDY DESIGN Single masked, prospective, randomized study. PATIENT SAMPLE Over a 4-year period, 66 patients (M:F=37:29) had ACDF using either dynamic (n=33) or static (n=33) plates for intractable radiculopathy as the result of degenerative cervical spine disease. Overall, 28 patients had single-level fusion and 38 had two or three levels fused. OUTCOME MEASURES Visual Analogue Pain scores (VASs), Neck Disability Index (NDI), and radiological criteria of established fusion. METHODS The qualifying subjects were randomized to receive ACDF using either fixed-holes (static) or the slotted-holes (dynamic) anterior cervical plates. Clinical and radiographic data were collected and analyzed. Paired-sample t test was used to correlate clinical and radiological outcomes and General Linear Model Analysis of Variance (GLM ANOVA) with repeated measures was used to detect outcome differences between the two groups for single and multiple fusions. RESULTS At a mean follow-up of 16 months (range, 12-24), 49 patients (73.7%) had clinical success and 56 (85%) showed radiological fusion. Although clinical success was a predictor of fusion (p=.043), the reverse was not true (p=.61). In single-level fusion, no statistical difference of outcome was observed between the two groups but multilevel fusions with dynamic plate showed significantly lower VAS and NDI than those with static plates (p=.050). CONCLUSIONS Although clinical improvement is a good predictor of successful ACDF, radiological evidence of fusion alone is not reliable as a parameter of success. The design of plate does not affect the outcomes in single-level fusions but statistics indicate that multiple-level fusions may have better clinical outcome when a dynamic plate design is used.

Symptomatic adjacent segment disease after cervical total disc replacement: re-examining the clinical and radiological evidence with established criteria.

BACKGROUND CONTEXT Although several publications in the last decade have proved equality in safety and efficacy of the total disc replacement (TDR) to the anterior fusion procedure in cervical spine, the claim that TDR may reduce the incidence of adjacent segment disease (ASD) has not been corroborated by clinical evidence. PURPOSE We attempt to predict the true incidence of symptomatic ASD after TDR surgery in the cervical spine at one or two levels at a median follow-up period of 4 years. STUDY DESIGN A total of 763 patients were screened to participate in four different Food and Drug Administration device exemption trials for artificial cervical disc replacement at three collaborating institutions. Two hundred seventy-one patients qualified and enrolled in the trials. One hundred seventy-three randomized to receive artificial disc replacement surgery, and 167 have completed a 4-year or longer follow-up. OUTCOME MEASURES Patients experiencing cervical radiculopathy symptoms in the follow-up period were worked-up with clinical examinations, magnetic resonance imaging of the cervical spine, and other diagnostic studies. Once a clinical correlation was established with the imaging evidence of adjacent segment degeneration, a careful record was maintained to document the subsequent medical and/or surgical treatment received by these patients. Statistical analysis was performed to determine the true incidence of and factors affecting the ASD after cervical disc replacement in these patients. RESULTS Twenty-six patients (15.2%) were identified to satisfy our criteria for ASD at the median follow-up of 51 months, with the annual incidence of 3.1% as calculated by life tables. The actuarial 5-year freedom from ASD rate was 71.6%±0.6%, and the mean period for freedom from ASD was 70.4±2.1 months. CONCLUSIONS The incidence of symptomatic ASD after cervical TDR is 3.1% annually regardless of the patients age, sex, smoking habits, and design of the TDR device. The presence of osteopenia and lumbar degenerative disease significantly increase the risk of developing ASD after anterior cervical surgery.

Comparison of pressure effects on adjacent disk levels after 2-level lumbar constructs: fusion, hybrid, and total disk replacement

BACKGROUND With increasing advocacy for the use of TDR procedure as a surgical alternative to fusion in the management of lumbar DDD, intradiskal pressures at the adjacent levels of spine have generated considerable interest. The common belief is that adjacent-level disk pressures will be lower after a TDR as opposed to conventional fusion. The aim of this study is to present the effect of different constructs on adjacent-level disk pressures in lumbar spine. We hypothesized that the adjacent-segment disk pressures after 1- and 2-level TDR and/or a fusion-TDR hybrid procedure will show significant variance within physiological range of motion. METHODS Six adult spine segments T12-S1 with intact ligaments were harvested from cadavers and held firmly in a specially designed fixture. Intradiskal pressures, in motions of flexion, extension, and lateral bending, at L2-L3 and L3-L4 were measured using needle transducers after 2-level TDR L4 through S1, hybrid procedure, and 2-level fusion L4-S1 with femoral ring allograft and pedicle screws. RESULTS The pressures with lateral bending were not significantly lower than those with flexion and extension at both levels (P = .18). Although TDR and hybrid specimens recorded slightly lower pressures specifically during lateral bending, no statistical difference in pressures could be detected when movements were combined with various procedures. CONCLUSION Contrary to the assumed hypothesis, the pressures at the adjacent-level disks (L3-4 and L2-3) did not depend upon the stabilization procedure (2-level disk replacement, hybrid, or 2-level fusion) performed after 2-level diskectomy in the lumbosacral spine.

Implant design may influence delayed heterotopic ossification after total disk arthroplasty in lumbar spine

BACKGROUND As total disk arthroplasty (TDA) gains increasing acceptance as an alternative to fusion for degenerative disk disease of the lumbar spine, new complications are encountered by the physicians during and after the procedure. We hereby report a complication after TDA in the lumbar spine that is in variance from previously proposed theories and suggests the possibility of implant design as one of the etiologic factors. The purpose of the present submission is to report a case of delayed heterotopic ossification (HO) after TDA that suggests that the keel-based design of the implant might have contributed to the etiology. CASE DESCRIPTION The patient underwent TDA for L3-4 degenerative disk disease and had fusion surgery for L5-S1 disease about 6 months later. During follow-up, development of significant HO was noticed at the L3 and L4 level. Radiologic studies revealed the origin of HO to be the keel cut made in the body of L3 to accommodate the keel-based artificial disk. CONCLUSION The exact etiology of HO after TDA is not clear. The presented anecdote points toward vertebral body trauma due to the design of the implant as a possible factor that needs to be studied more elaborately.

Short-term outcomes of lateral lumbar interbody fusion without decompression for the treatment of symptomatic degenerative spondylolisthesis at L4–5

OBJECTIVE Recently, authors have called into question the utility and complication index of the lateral lumbar interbody fusion procedure at the L4-5 level. Furthermore, the need for direct decompression has also been debated. Here, the authors report the clinical and radiographic outcomes of transpsoas lumbar interbody fusion, relying only on indirect decompression to treat patients with neurogenic claudication secondary to Grade 1 and 2 spondylolisthesis at the L4-5 level. METHODS The authors conducted a retrospective evaluation of 18 consecutive patients with Grade 1 or 2 spondylolisthesis from a prospectively maintained database. All patients underwent a transpsoas approach, followed by posterior percutaneous instrumentation without decompression. The Oswestry Disability Index (ODI) and SF-12 were administered during the clinical evaluations. Radiographic evaluation was also performed. The mean follow-up was 6.2 months. RESULTS Fifteen patients with Grade 1 and 3 patients with Grade 2 spondylolisthesis were identified and underwent fusion at a total of 20 levels. The mean operative time was 165 minutes for the combined anterior and posterior phases of the operation. The estimated blood loss was 113 ml. The most common cage width in the anteroposterior dimension was 22 mm (78%). Anterior thigh dysesthesia was identified on detailed sensory evaluation in 6 of 18 patients (33%); all patients experienced resolution within 6 months postoperatively. No patient had lasting sensory loss or motor deficit. The average ODI score improved 26 points by the 6-month follow-up. At the 6-month follow-up, the SF-12 mean Physical and Mental Component Summary scores improved by 11.9% and 9.6%, respectively. No patient required additional decompression postoperatively. CONCLUSIONS This study offers clinical results to establish lateral lumbar interbody fusion as an effective technique for the treatment of Grade 1 or 2 degenerative spondylolisthesis at L4-5. The use of this surgical approach provides a minimally invasive solution that offers excellent arthrodesis rates as well as favorable clinical and radiological outcomes, with low rates of postoperative complications. However, adhering to the techniques of transpsoas lateral surgery, such as minimal table break, an initial look-and-see approach to the psoas, clear identification of the plexus, minimal cranial caudal expansion of the retractor, mobilization of any traversing sensory nerves, and total psoas dilation times less than 20 minutes, ensures the lowest possible complication profile for both visceral and neural injuries even in the narrow safe zones when accessing the L4-5 disc space in patients with degenerative spondylolisthesis.

Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years—Prevalence, Progression, Clinical Implications, and Risk Factors

ABSTRACT Background: Heterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics. Methods: Posthoc, multiple-phase analysis of radiographic, clinical, and demographic data for CTDR as it relates to HO was performed. HO was radiographically graded for 164 one-level and 225 two-level CTDR patients using the McAfee and Mehren system. Analysis was performed to correlate HO grades to clinical outcomes and to evaluate potential risk factors for the development of HO using demographics and baseline clinical measures. Results: At 7 years, 1-level clinically relevant HO grades were 17.6% grade 3 and 11.1% grade 4. Two-level clinically relevant HO grades, evaluated using the highest patient grade, were 26.6% grade 3 and 10.8% grade 4. Interaction between HO and time revealed significance for neck disability index (NDI; P = .04) and Visual Analog Scale (VAS) neck pain (P = .02). When analyzed at each time point NDI was significant at 48–84 months and VAS neck at 60 months. For predictors 2 analyses were run; odds ratios indicated follow-up visit, male sex, and preoperative VAS neck pain are related to HO development, whereas hazard ratios indicated male sex, obesity, endplate coverage, levels treated, and preoperative VAS neck pain. Conclusions: This is the largest study to report HO rates, and related outcomes and risk factors. To develop an accurate predictive model, further large-scale analyses need to be performed. Based on the results reported here, clinically relevant HO should be more accurately described as motion-restricting HO until a definitive link to outcomes has been established.

Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion

Background Bone graft material for lumbar fusion was historically autologous bone graft (ABG). In recent years alternatives such as allograft, demineralized bone matrix (DBM), ceramics, and bone morphogenetic protein (BMP) have gained favor, although the complications of these are not fully understood. Bioactive amniotic suspension (BAS) with allograft is a new class of material derived from human amniotic tissue. Methods Eligible patients receiving a one or two level lumbar interbody fusion with Nucel, a BAS with allograft, were contacted and scheduled for a mininmim 12 month follow-up visit. Patients were evaluated for fusion using CTs and plain radiographs. Clincal outcomes, including ODI, VAS back and leg were collected, as well as comorbidities including BMI, smoking status, diabetes and previous lumbar surgery. Results One-level patients (N=38) were 71.1% female with mean age of 58.4 ± 12.7 and mean BMI of 30.6 ± 6.08. Two-level patients (N=34) were 58.8% female with mean age of 49.3 ±10.9 and mean BMI of 30.1 ± 5.82. Kinematic fusion was achieved in 97.4% of one-level patients and 100% of two-level patients. Baseline comorbidities were present in 89.5% of one-level patients and 88.2% of two-level patients. No adverse events related to BAS were reported in this study. Conclusion Fusion status is evaluated with many different biologics and varying methods in the literature. BAS with allograft in this study demonstrated high fusion rates with no complications within a largely comorbid population. Although a small population, BAS with allograft results were encouraging for one and two-level lumbar interbody fusion in this study. Further prospective studies should be conducted to investigate safety and efficacy in a larger population.