Tag: adjacent level disease

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Hounsfield Unit as a Predictor of Adjacent-Level Disease in Lumbar Interbody Fusion Surgery

Neurosurgery 91:146–149, 2022

Bone density has been associated with a successful fusion rate in spine surgery. Hounsfield units (HUs) have more recently been evaluated as an indirect representation of bone density. Low preoperative HUs may be an early indicator of global disease and chronic process and, therefore, indicative of the need for future reoperation.

OBJECTIVE: To assess preoperative HUs and their association with future adjacent segment disease requiring surgical intervention through retrospective study.

METHODS: Patients who underwent lumbar interbody fusion at a single institution between 2007 and 2016 were retrospectively reviewed. Hounsfield unit values were measured from preoperative computed tomography (CT) using sagittal images, encircling cancellous portion of the vertebral body. Patient charts were reviewed for follow-up data and adjacent-level disease development.

RESULTS: A total of 793 patients (age: 56.1 ± 13.7 years, 54.4% female) were included in this study. Twenty-two patients required surgical intervention for adjacent segment disease. Patients who underwent lumbar interbody fusion and did not subsequently require surgical intervention for adjacent-level disease were found to have a higher mean preoperative HU than patients who did require reoperation (180.7 ± 70.0 vs 148.4 ± 8.1, P = .032). Preoperative CT HU was a significant independent predictor for the requirement of adjacent-level surgery after spinal arthrodesis (odds ratio = 0.891 [0.883-0.899], P = .029).

CONCLUSION: Patients who underwent lumbar interbody fusion that did not require reoperation for adjacent-level degeneration were found to have a higher mean preoperative HU than patients who did require surgical intervention. Lower preoperative CT HU was a significant independent predictor for the requirement of adjacent-level surgery after spinal arthrodesis.

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Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion

Neurosurgery 84:347–354, 2019

Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN  Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability.

OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS).

METHODS: Prospective randomized trial data were analyzed comparing BRYANR  Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE   Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS.

RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN  disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69◦ vs 0.60◦). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN and Prestige ST demonstrate that BRYAN  and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023).

CONCLUSION: Compared with ACDF, fewer patients with the BRYAN  disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

 

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The Influence of Pelvic Incidence and Lumbar Lordosis Mismatch on Development of Symptomatic Adjacent Level Disease Following Single-Level Transforaminal Lumbar Interbody Fusion

Neurosurgery 80:880–886, 2017

Annual incidence of symptomatic adjacent level disease (ALD) following lumbar fusion surgery ranges from 0.6% to 3.9% per year. Sagittal malalignment may contribute to the development of ALD.

OBJECTIVE: To describe the relationship between pelvic incidence-lumbar lordosis (PI-LL) mismatch and the development of symptomatic ALD requiring revision surgery following single-level transforaminal lumbar interbody fusion for degenerative lumbar spondylosis and/or low-grade spondylolisthesis.

METHODS: All patients who underwent a single-level transforaminal lumbar interbody fusion at either L4/5 or L5/S1 between July 2006 and December 2012 were analyzed for pre- and postoperative spinopelvic parameters. Using univariate and logistic regression analysis,we compared the spinopelvic parameters of those patients who required revision surgery against those patients who did not develop symptomatic ALD. We calculated the predictive value of PI-LL mismatch.

RESULTS: One hundred fifty-nine patients met the inclusion criteria. The results noted that, for a 1◦ increase in PI-LL mismatch (preop and postop), the odds of developing ALD requiring surgery increased by 1.3 and 1.4 fold, respectively, which were statistically significant increases. Based on our analysis, a PI-LL mismatch of >11◦ had a positive predictive value of 75% for the development of symptomatic ALD requiring revision surgery.

CONCLUSIONS: A high PI-LL mismatch is strongly associated with the development of symptomatic ALD requiring revision lumbar spine surgery. The development of ALD may represent a global disease process as opposed to a focal condition. Spine surgeons may wish to consider assessment of spinopelvic parameters in the evaluation of degenerative lumbar spine pathology.

 

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Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion

J Neurosurg Spine 23:558–573, 2015

This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF).

METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings.

RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01–0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability.

CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.

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Adjacent Segment Disease After Anterior Cervical Discectomy and Fusion in a Large Series

ASD1

Neurosurgery 74:139–146, 2014

Adjacent segment disease (ASD) development is known to occur after anterior cervical discectomy and fusion (ACDF).

OBJECTIVE: To study the relationship between index ACDF levels and the location of ASD development (above/below), as well as the effect of fusion length on ASD development.

METHODS: We report 888 patients who underwent ACDF for cervical spondylosis over a twenty-year period at a single institution. Of these patients, 108 had re-do surgery due to symptomatic ASD. Patients were followed for an average of 92.4 6 52.6 months after the index ACDF.

RESULTS: In agreement with previous ACDF case series, we found the highest rates of cervical spinal degenerative disease requiring surgery at C5/C6, followed by C6/C7. Interestingly, neither the inherent location of index ACDF nor the length of instrumented arthrodesis appeared to correlate with the propensity to develop ASD. However, patients were more likely to develop ASD above the index level of fusion. This was true even for patients undergoing a second revision surgery due to recurrent ASD. Importantly, our data are consistent with existing in vitro biomechanical data in cadaveric spines.

CONCLUSION: We describe in detail the location and length of arthrodesis for index ACDFs, as well as first and second revision fusion surgeries in one of the largest Western cohorts in the literature. Our findings support the theory that iatrogenically introduced stress and instability at adjacent spinal segments contribute to the pathogenesis of ASD.

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Clinical Outcomes of Bryan Cervical Disc Arthroplasty A Prospective, Randomized, Controlled, Single Site Trial With 48-Month Follow-up

J Spinal Disord Tech 2010;23:367–371

Study Design: Prospective, randomized, controlled. Level 1 evidence.

Objective: To report functional outcomes at 48 months followup on prospectively randomized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion (ACDF) at a single site.

Summary of Background Data: Surgical treatment of cervical disc pathology can involve discectomy and fusion (ACDF), the gold standard technique. The safety and effectiveness of this procedure has been established and demonstrated in the literature, however, limitations have evolved and alternatives such as disc replacement are being investigated. Intervertebral disc replacement is designed to preserve motion, both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration. New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement. A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF. Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts.

Methods: A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospectively randomized study investigating ACDF versus Bryan cervical disc prosthesis. Functional outcomes are now reported at 48 months follow-up for our cohort of participants. Neck disability index score (NDI), VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported.

Results: Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI, neck/arm pain VAS scores, and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts. The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10. For ACDF preoperative NDI score was also 51 and at 48 months 16.7. At 48 months NDI success, measured by Z15 points NDI improvement demonstrated a 93.3% success for Bryan arthroplasty and an 82.4%success for ACDF. VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6. VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1. Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8. For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7. These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years. During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group (ACDF) and only 1 in our investigational group (Bryan). Of the 6 surgeries in the control group performed, 3 or 12% to date were for adjacent level degenerative disease and 1 or 4% for remote level degenerative disc disease. The remaining 2 surgeries were performed on the same patient for a pseudarthrosis. In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5%.

Conclusions: At 48 months, cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution. There has been no degradation of functional outcomes from 24 to 48 months for NDI, VAS of neck and arm, and SF-36. There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date.

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