Tag: adjacent segment pathology

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Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

J Neurosurg Spine 36:945–953, 2022

Artificial disc replacement (ADR) is designed to preserve motion and thus protect against adjacent segment pathology (ASP) and act as an alternative treatment to fusion surgery. The question remains, how well do ADR devices perform after 10 years of follow-up compared with fusion surgery in terms of patient satisfaction, sustainability, and protection against ASP?

METHODS This was the 10-year follow-up study of 153 participants who underwent ADR or fusion surgery after anterior decompression due to cervical degenerative radiculopathy (ISRCTN registration no. 44347115). Scores on the Neck Disability Index (NDI), EQ-5D, and visual analog scale for neck and arm pain were obtained from the Swedish Spine Registry and analyzed using ANCOVA. Information about secondary surgical procedures was collected from medical records and presented as Kaplan-Meier curves. MRI and flexion-extension radiography were performed, and ASP was
graded according to the Miyazaki classification system.

RESULTS Ten participants were lost to follow-up, which left 143 participants (80 underwent ADR and 65 underwent anterior cervical discectomy and fusion). There were no differences between groups in terms of patient-reported outcome measures (10-year difference in NDI scores 1.7 points, 95% CI −5.1 to 8.5, p = 0.61). Nineteen (24%) participants in the ADR group compared with 9 (14%) in the fusion group underwent secondary surgical procedures. The higher reoperation rate of the ADR group was mainly due to 11 female participants with device loosening. The rates of reoperation due
to ASP were similar between groups, which was confirmed with MRI assessment of ASP that also showed no differences between the groups (p = 0.21).
CONCLUSIONS This was the first 10-year follow-up study to compare ADR with fusion surgery and to provide MRI information for the assessment of ASP. The authors found no benefit of ADR over fusion surgery after anterior  decompression for cervical degenerative radiculopathy.

 

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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.

 

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Heterotopic ossification and radiographic adjacent-segment disease after cervical disc arthroplasty

J Neurosurg Spine 31:660–669, 2019

Cervical disc arthroplasty (CDA) is an accepted motion-sparing technique associated with favorable patient outcomes. However, heterotopic ossification (HO) and adjacent-segment degeneration are poorly understood adverse events that can be observed after CDA. The purpose of this study was to retrospectively examine 1) the effect of the residual exposed endplate (REE) on HO, and 2) identify risk factors predicting radiographic adjacent-segment disease (rASD) in a consecutive cohort of CDA patients.

METHODS A retrospective cohort study was performed on consecutive adult patients (≥ 18 years) who underwent 1- or 2-level CDA at the University of Calgary between 2002 and 2015 with > 1-year follow-up. REE was calculated by subtracting the anteroposterior (AP) diameter of the arthroplasty device from the native AP endplate diameter measured on lateral radiographs. HO was graded using the McAfee classification (low grade, 0–2; high grade, 3 and 4). Change in AP endplate diameter over time was measured at the index and adjacent levels to indicate progressive rASD.

RESULTS Forty-five patients (58 levels) underwent CDA during the study period. The mean age was 46 years (SD 10 years). Twenty-six patients (58%) were male. The median follow-up was 29 months (IQR 42 months). Thirty-three patients (73%) underwent 1-level CDA. High-grade HO developed at 19 levels (33%). The mean REE was 2.4 mm in the high-grade HO group and 1.6 mm in the low-grade HO group (p = 0.02). On multivariable analysis, patients with REE > 2 mm had a 4.5-times-higher odds of developing high-grade HO (p = 0.02) than patients with REE ≤ 2 mm. No significant relationship was observed between the type of artificial disc and the development of high-grade HO (p = 0.1). RASD was more likely to develop in the lower cervical spine (p = 0.001) and increased with time (p < 0.001). The presence of an artificial disc was highly protective against degenerative changes at the index level of operation (p < 0.001) but did not influence degeneration in the adjacent segments.

CONCLUSIONS In patients undergoing CDA, high-grade HO was predicted by REE. Therefore, maximizing the implant-endplate interface may help to reduce high-grade HO and preserve motion. RASD increases in an obligatory manner following CDA and is highly linked to specific levels (e.g., C6–7) rather than the presence or absence of an adjacent arthroplasty device. The presence of an artificial disc is, however, protective against further degenerative change at the index level of operation.

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Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes

J Neurosurg Spine 30:323–331, 2019

The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, longterm follow-up evaluations using MRI are needed to investigate if this intent is achieved.

METHODS The authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.

RESULTS Scores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.

CONCLUSIONS In patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.

Clinical trial registration no.: 44347115 (ISRCTN).

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Artificial disc replacement versus fusion in patients with cervical degenerative disc disease with radiculopathy: 5-year outcomes from the National Swedish Spine Register

J Neurosurg Spine 30:159–167, 2019

The long-term efficacy of artificial disc replacement (ADR) surgery compared with fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy has not previously been investigated in a population-based setting.

METHODS All patients with cervical degenerative disc disease and radiculopathy who were in the national Swedish Spine Registry (Swespine) beginning in January 1, 2006, were eligible for the study. Follow-up information was obtained up to November 15, 2017. The authors compared, using propensity score matching, patients treated with anterior decompression and insertion of an ADR with patients who underwent anterior decompression combined with fusion surgery.
The primary outcome was the Neck Disability Index (NDI), a patient-reported function score ranging from 0% to 100%, with higher scores indicating greater disability and a minimum clinically important difference of > 15%.

RESULTS A total of 3998 patients (2018:1980 women/men) met the inclusion criteria, of whom 204 had undergone arthroplasty and 3794 had undergone fusion. After propensity score matching, 185 patients with a mean age of 49.7 years remained in each group. Scores on the NDI were approximately halved in both groups after 5 years, but without a significant mean difference in NDI (3.0%; 95% CI -8.4 to 2.4; p = 0.28) between the groups. There were no differences between the groups in EuroQol–5 Dimensions or in pain scores for the neck and arm.

CONCLUSIONS In patients with cervical degenerative disc disease and radiculopathy, decompression plus ADR surgery did not result in a clinically important difference in outcomes after 5 years, compared with decompression and fusion surgery.

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Surgical outcomes of PLIF with CBT screw fixation

surgical-outcomes-of-plif-with-cbt-screw-fixation

J Neurosurg Spine 25:591–595, 2016

Several biomechanical studies have demonstrated the favorable mechanical properties of the cortical bone trajectory (CBT) screw. However, no reports have examined surgical outcomes of posterior lumbar interbody fusion (PLIF) with CBT screw fixation for degenerative spondylolisthesis (DS) compared with those after PLIF using traditional pedicle screw (PS) fixation. The purposes of this study were thus to elucidate surgical outcomes after PLIF with CBT screw fixation for DS and to compare these results with those after PLIF using traditional PS fixation.

Methods Ninety-five consecutive patients underwent PLIF with CBT screw fixation for DS (CBT group; mean followup 35 months). A historical control group consisted of 82 consecutive patients who underwent PLIF with traditional PS fixation (PS group; mean follow-up 40 months). Clinical status was assessed using the Japanese Orthopaedic Association (JOA) scale score. Fusion status was assessed by dynamic plain radiographs and CT. The need for additional surgery and surgery-related complications was also evaluated.

Results The mean JOA score improved significantly from 13.7 points before surgery to 23.3 points at the latest follow-up in the CBT group (mean recovery rate 64.4%), compared with 14.4 points preoperatively to 22.7 points at final follow-up in the PS group (mean recovery rate 55.8%; p < 0.05). Solid spinal fusion was achieved in 84 patients from the CBT group (88.4%) and in 79 patients from the PS group (96.3%, p > 0.05). Symptomatic adjacent-segment disease developed in 3 patients from the CBT group (3.2%) compared with 9 patients from the PS group (11.0%, p < 0.05).

Conclusions PLIF with CBT screw fixation for DS provided comparable improvement of clinical symptoms with PLIF using traditional PS fixation. However, the successful fusion rate tended to be lower in the CBT group than in the PS group, although the difference was not statistically significant between the 2 groups.

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Adjacent Segment Pathology Requiring Reoperation After Anterior Cervical Arthrodesis

Outcomes After Anterior Cervical Discectomy and Fusion in Professional AthletesSpine 2015;40:E571–E577

Study Design. A retrospective study.

Objective. The purpose of this study was to determine, using survivorship analysis, the rate of adjacent segment pathology (ASP) development and to identify the risk factors for reoperation.

Summary of Background Data. The study of Hilibrand defi ned “adjacent segment disease” as symptomatic radiculopathy or myelopathy due to an adjacent segment documented on 2 consecutive offi ce visits. In addition to being somewhat subjective, their criterion is not as practical as identifying the rate of adjacent pathology by the need for reoperation.

Methods. This was a retrospective analysis of 1038 consecutive patients who underwent primary anterior cervical spine arthrodesis for radiculopathy and/or myelopathy by 1 surgeon. Annual incidence and prevalence of ASP requiring surgery were calculated and survivorship was determined. We used the Cox regression for risk factor analysis.

Results. Secondary surgery on adjacent segments occurred at a relatively constant rate of 2.4% per year (95% confi dence interval, 1.9–3.0). The Kaplan-Meier analysis predicted that 22.2% of patients would need reoperation at adjacent segments by 10 years postoperatively. Factors increasing the risk were smoking, female sex, and the number of arthrodesis segments. One or 2-segment arthrodesis had an 1.8 times greater risk than arthrodesis involving 3 or more segments. Age, neurological diagnosis, diabetes, Klippel- Feil syndrome, and noncontiguous segmental-type ossifi cation of posterior longitudinal ligament were not signifi cant risks.

Conclusion. Patients treated with 1- or 2-segment anterior cervical arthrodesis are more likely to develop ASP than those treated with arthrodesis involving 3 or more segments. Smokers and women had a higher ASP reoperation rate. Our series, the largest in the literature, predicts that 22.2% of patients will require reoperation for ASP within 10 years, substantially higher than the Hilibrand study.

Level of Evidence: 3

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