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Augmented PMMA distribution: improvement of mechanical property and reduction of leakage rate of a fenestrated pedicle screw with diameter-tapered perforations

Quan-chang Tan, Jian-wei Wu, Fei Peng, Yuan Zang, Yang Li, Xiong Zhao, Wei Lei, and Zi-xiang Wu

OBJECTIVE

This study investigated the optimum injection volume of polymethylmethacrylate (PMMA) to augment a novel fenestrated pedicle screw (FPS) with diameter-tapered perforations in the osteoporotic vertebral body, and how the distribution characteristics of PMMA affect the biomechanical performance of this screw.

METHODS

Two types of FPSs were designed (FPS-A, composed of 6 perforations with an equal diameter of 1.2 mm; and FPS-B, composed of 6 perforations each with a tapered diameter of 1.5 mm, 1.2 mm, and 0.9 mm from tip to head. Each of 28 human cadaveric osteoporotic vertebrae were randomly assigned to 1 of 7 groups: FPS-A1.0: FPS-A+1.0 ml PMMA; FPS-A1.5: FPS-A+1.5 ml PMMA; FPS-A2.0: FPS-A+2.0 ml PMMA; FPS-B1.0: FPS-B+1.0 ml PMMA; FPS-B1.5: FPS-B+1.5 ml PMMA; FPS-B2.0: FPS-B+2.0 ml PMMA; and conventional pedicle screws (CPSs) without PMMA. After the augmentation, 3D CT was performed to assess the cement distribution characteristics and the cement leakage rate. Axial pullout tests were performed to compare the maximum pullout force thereafter.

RESULTS

The CT construction images showed that PMMA bone cement formed a conical mass around FPS-A and a cylindrical mass around FPS-B. When the injection volume was increased from 1.0 ml to 2.0 ml, the distribution region of the PMMA cement was enlarged, the PMMA was distributed more posteriorly, and the risk of leakage was increased. When the injection volume reached 2.0 ml, the risk of cement leakage was lower for screws having diameter-tapered perforations. The pullout strengths of the augmented FPS-A groups and FPS-B groups were higher than that of the CPS group (p < 0.0001). All FPS-B groups had a higher pullout strength than the FPS-A groups.

CONCLUSIONS

The diameter of the perforations affects the distribution of PMMA cement. The diameter-tapered design enabled PMMA to form larger bone-PMMA interfaces and achieve a relatively higher pullout strength, although statistical significance was not reached. Study results indicated 1.5-ml of PMMA was a conservative volume for PMMA augmentation; more cement injection would significantly increase the risk of cement leakage.

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Dynamic stabilization for L4–5 spondylolisthesis: comparison with minimally invasive transforaminal lumbar interbody fusion with more than 2 years of follow-up

Chao-Hung Kuo, Peng-Yuan Chang, Jau-Ching Wu, Hsuan-Kan Chang, Li-Yu Fay, Tsung-Hsi Tu, Henrich Cheng, and Wen-Cheng Huang

OBJECTIVE

In the past decade, dynamic stabilization has been an emerging option of surgical treatment for lumbar spondylosis. However, the application of this dynamic construct for mild spondylolisthesis and its clinical outcomes remain uncertain. This study aimed to compare the outcomes of Dynesys dynamic stabilization (DDS) with minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) for the management of single-level spondylolisthesis at L4–5.

METHODS

This study retrospectively reviewed 91 consecutive patients with Meyerding Grade I spondylolisthesis at L4–5 who were managed with surgery. Patients were divided into 2 groups: DDS and MI-TLIF. The DDS group was composed of patients who underwent standard laminectomy and the DDS system. The MI-TLIF group was composed of patients who underwent MI-TLIF. Clinical outcomes were evaluated by visual analog scale for back and leg pain, Oswestry Disability Index, and Japanese Orthopaedic Association scores at each time point of evaluation. Evaluations included radiographs and CT scans for every patient for 2 years after surgery.

RESULTS

A total of 86 patients with L4–5 spondylolisthesis completed the follow-up of more than 2 years and were included in the analysis (follow-up rate of 94.5%). There were 64 patients in the DDS group and 22 patients in the MI-TLIF group, and the overall mean follow-up was 32.7 months. Between the 2 groups, there were no differences in demographic data (e.g., age, sex, and body mass index) or preoperative clinical evaluations (e.g., visual analog scale back and leg pain, Oswestry Disability Index, and Japanese Orthopaedic Association scores). The mean estimated blood loss of the MI-TLIF group was lower, whereas the operation time was longer compared with the DDS group (both p < 0.001). For both groups, clinical outcomes were significantly improved at 6, 12, 18, and 24 months after surgery compared with preoperative clinical status. Moreover, there were no differences between the 2 groups in clinical outcomes at each evaluation time point. Radiological evaluations were also similar and the complication rates were equally low in both groups.

CONCLUSIONS

At 32.7 months postoperation, the clinical and radiological outcomes of DDS were similar to those of MI-TLIF for Grade I degenerative spondylolisthesis at L4–5. DDS might be an alternative to standard arthrodesis in mild lumbar spondylolisthesis. However, unlike fusion, dynamic implants have issues of wearing and loosening in the long term. Thus, the comparable results between the 2 groups in this study require longer follow-up to corroborate.

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Dynesys dynamic stabilization–related facet arthrodesis

Li-Yu Fay, Peng-Yuan Chang, Jau-Ching Wu, Wen-Cheng Huang, Chun-Hao Wang, Tzu-Yun Tsai, Tsung-Hsi Tu, Hsuan-Kan Chang, Ching-Lan Wu, and Henrich Cheng

OBJECTIVE

Dynamic stabilization devices are designed to stabilize the spine while preserving some motion. However, there have been reports demonstrating limited motion at the instrumented level of the lumbar spine after Dynesys dynamic stabilization (DDS). The causes of this limited motion and its actual effects on outcomes after DDS remain elusive. In this study, the authors investigate the incidence of unintended facet arthrodesis after DDS and clinical outcomes.

METHODS

This retrospective study included 80 consecutive patients with 1- or 2-level lumbar spinal stenosis who underwent laminectomy and DDS. All medical records, radiological data, and clinical evaluations were analyzed. Imaging studies included pre- and postoperative radiographs, MR images, and CT scans. Clinical outcomes were measured by a visual analog scale (VAS) for back and leg pain, the Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores. Furthermore, all patients had undergone postoperative CT for the detection of unintended arthrodesis of the facets at the indexed level, and range of motion was measured on standing dynamic radiographs.

RESULTS

A total of 70 patients (87.5%) with a mean age of 64.0 years completed the minimum 24-month postoperative follow-up (mean duration 29.9 months). Unintended facet arthrodesis at the DDS instrumented level was demonstrated by CT in 38 (54.3%) of the 70 patients. The mean age of patients who had facet arthrodesis was 9.8 years greater than that of the patients who did not (68.3 vs 58.5 years, p = 0.009). There were no significant differences in clinical outcomes, including VAS back and leg pain, ODI, and JOA scores between patients with and without the unintended facet arthrodesis. Furthermore, those patients older than 60 years were more likely to have unintended facet arthrodesis (OR 12.42) and immobile spinal segments (OR 2.96) after DDS. Regardless of whether unintended facet arthrodesis was present or not, clinical evaluations demonstrated improvement in all patients (all p < 0.05).

CONCLUSIONS

During the follow-up of more than 2 years, unintended facet arthrodesis was demonstrated in 54.3% of the patients who underwent 1- or 2-level DDS. Older patients (age > 60 years) were more likely to have unintended facet arthrodesis and subsequent immobile spinal segments. However, unintended facet arthrodesis did not affect the clinical outcomes during the study period. Further evaluations are needed to clarify the actual significance of this phenomenon.

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Letter to the Editor: Differences between Dynamic Cervical Implant and artificial discs

Chun-Hao Wang, Peng-Yuan Chang, Hsuan-Kan Chang, Jau-Ching Wu, Wen-Cheng Huang, Li-Yu Fay, Tsung-Hsi Tu, Ching-Lan Wu, and Henrich Cheng

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Letter to the Editor. Hybrid cervical disc arthroplasty for cervical myelopathy associated with congenital cervical stenosis

Yawei Li, Guohua Lv, and Bing Wang

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Is cervical disc arthroplasty good for congenital cervical stenosis?

Peng-Yuan Chang, Hsuan-Kan Chang, Jau-Ching Wu, Wen-Cheng Huang, Li-Yu Fay, Tsung-Hsi Tu, Ching-Lan Wu, and Henrich Cheng

OBJECTIVE

Cervical disc arthroplasty (CDA) has been demonstrated to be as safe and effective as anterior cervical discectomy and fusion (ACDF) in the management of 1- and 2-level degenerative disc disease (DDD). However, there has been a lack of data to address the fundamental discrepancy between the two surgeries (CDA vs ACDF), and preservation versus elimination of motion, in the management of cervical myelopathy associated with congenital cervical stenosis (CCS). Although younger patients tend to benefit more from motion preservation, it is uncertain if CCS caused by multilevel DDD can be treated safely with CDA.

METHODS

Consecutive patients who underwent 3-level anterior cervical discectomy were retrospectively reviewed. Inclusion criteria were age less than 50 years, CCS (Pavlov ratio ≤ 0.82), symptomatic myelopathy correlated with DDD, and stenosis limited to 3 levels of the subaxial cervical (C3–7) spine. Exclusion criteria were ossification of the posterior longitudinal ligament, previous posterior decompression surgery (e.g., laminoplasty or laminectomy), osteoporosis, previous trauma, or other rheumatic diseases that might have caused the cervical myelopathy. All these patients who underwent 3-level discectomy were divided into 2 groups according to the strategies of management: preservation or elimination of motion (the hybrid-CDA group and the ACDF group). The hybrid-CDA group underwent 2-level CDA plus 1-level ACDF, whereas the ACDF group underwent 3-level ACDF. Clinical assessment was measured by the visual analog scales (VAS) for neck and arm pain, Japanese Orthopaedic Association (JOA) scores, and Nurick grades. Radiographic outcomes were measured using dynamic radiographs for evaluation of range of motion (ROM).

RESULTS

Thirty-seven patients, with a mean (± SD) age of 44.57 ± 5.10 years, were included in the final analysis. There was a male predominance in this series (78.4%, 29 male patients), and the mean follow-up duration was 2.37 ± 1.60 years. There were 20 patients in the hybrid-CDA group, and 17 in the ACDF group. Both groups demonstrated similar clinical improvement at 2 years' follow-up. These patients with 3-level stenosis experienced significant improvement after either type of surgery (hybrid-CDA and ACDF). There were no significant differences between the 2 groups at each of the follow-up visits postoperatively. The preoperative ROM over the operated subaxial levels was similar between both groups (21.9° vs 21.67°; p = 0.94). Postoperatively, the hybrid-CDA group had significantly greater ROM (10.65° vs 2.19°; p < 0.001) than the ACDF group. Complications, adverse events, and reoperations in both groups were similarly low.

CONCLUSIONS

Hybrid-CDA yielded similar clinical improvement to 3-level ACDF in patients with myelopathy caused by CCS. In this relatively young group of patients, hybrid-CDA demonstrated significantly more ROM than 3-level ACDF without adjacent-segment disease (ASD) at 2 years' follow-up. Therefore, hybrid-CDA appears to be an acceptable option in the management of CCS. The strategy of motion preservation yielded similar improvements of cervical myelopathy to motion elimination (i.e., ACDF) in patients with CCS, while the theoretical benefit of reducing ASD required further validation.

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The importance of atlantoaxial fixation after odontoidectomy

Peng-Yuan Chang, Yu-Shu Yen, Jau-Ching Wu, Hsuan-Kan Chang, Li-Yu Fay, Tsung-Hsi Tu, Ching-Lan Wu, Wen-Cheng Huang, and Henrich Cheng

OBJECT

Although anterior odontoidectomy has been widely accepted as a procedure for decompression of the craniovertebral junction (CVJ), postoperative biomechanical instability has not been well addressed. There is a paucity of data on the necessity for and choice of fixation.

METHODS

The authors conducted a retrospective review of consecutively treated patients with basilar invagination who underwent anterior odontoidectomy and various types of posterior fixation. Posterior fixation included 1 of 3 kinds of constructs: occipitocervical (OC) fusion with atlantoaxial (AA) fixation, OC fusion without AA fixation, or AA-only (without OC) fixation. On the basis of the use or nonuse of AA fixation, these patients were assigned to either the AA group, in which the posterior fixation surgery involved both the atlas and axis simultaneously, regardless of whether the patient underwent OC fusion, or the non-AA group, in which the OC fusion construct spared the atlas, axis, or both. Clinical outcomes and neurological function were compared. Radiological results at each time point (i.e., before and after odontoidectomy and after fixation) were assessed by calculating the triangular area causing ventral indentation of the brainstem in the CVJ.

RESULTS

Data obtained in 14 consecutively treated patients with basilar invagination were analyzed in this series; the mean follow-up time was 5.75 years. The mean age was 53.58 years; there were 7 males and 7 females. The AA and non-AA groups consisted of 7 patients each. The demographic data of both groups were similar. Overall, there was significant improvement in neurological function after the operation (p = 0.03), and there were no differences in the postoperative Nurick grades between the 2 groups (p = 1.00). According to radiological measurements, significant decompression of the ventral brainstem was achieved stepwise in both groups by anterior odontoidectomy and posterior fixation; the mean ventral triangular area improved from 3.00 ± 0.86 cm2 to 2.08 ± 0.51 cm2 to 1.68 ± 0.59 cm2 (before and after odontoidectomy and after fixation, respectively; p < 0.05). The decompression gained by odontoidectomy (i.e., reduction of the ventral triangular area) was similar in the AA and non-AA groups (0.66 ± 0.42 cm2 vs 1.17 ± 1.42 cm2, respectively; p = 0.38). However, the decompression achieved by posterior fixation was significantly greater in the AA group than in the non-AA group (0.64 ± 0.39 cm2 vs 0.17 ± 0.16 cm2, respectively; p = 0.01).

CONCLUSIONS

Anterior odontoidectomy alone provides significant decompression at the CVJ. Adjuvant posterior fixation further enhances the extent of decompression after the odontoidectomy. Moreover, posterior fixation that involves AA fixation yields significantly more decompression of the ventral brainstem than OC fusion that spares AA fixation.

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Letters to the editor: Hypermobility accelerates adjacent-segment disease after ACDF?

Peng-Yuan Chang, Yu-Shu Yen, Jau-Ching Wu, Wen-Cheng Huang, Tsung-Hsi Tu, Li-Yu Fay, and Henrich Cheng

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Differences between C3–4 and other subaxial levels of cervical disc arthroplasty: more heterotopic ossification at the 5-year follow-up

Peng-Yuan Chang, Hsuan-Kan Chang, Jau-Ching Wu, Wen-Cheng Huang, Li-Yu Fay, Tsung-Hsi Tu, Ching-Lan Wu, and Henrich Cheng

OBJECTIVE

Several large-scale clinical trials demonstrate the efficacy of 1- and 2-level cervical disc arthroplasty (CDA) for degenerative disc disease (DDD) in the subaxial cervical spine, while other studies reveal that during physiological neck flexion, the C4–5 and C5–6 discs account for more motion than the C3–4 level, causing more DDD. This study aimed to compare the results of CDA at different levels.

METHODS

After a review of the medical records, 94 consecutive patients who underwent single-level CDA were divided into the C3–4 and non-C3–4 CDA groups (i.e., those including C4–5, C5–6, and C6–7). Clinical outcomes were measured using the visual analog scale for neck and arm pain and by the Japanese Orthopaedic Association scores. Postoperative range of motion (ROM) and heterotopic ossification (HO) were determined by radiography and CT, respectively.

RESULTS

Eighty-eight patients (93.6%; mean age 45.62 ± 10.91 years), including 41 (46.6%) female patients, underwent a mean follow-up of 4.90 ± 1.13 years. There were 11 patients in the C3–4 CDA group and 77 in the non-C3–4 CDA group. Both groups had significantly improved clinical outcomes at each time point after the surgery. The mean preoperative (7.75° vs 7.03°; p = 0.58) and postoperative (8.18° vs 8.45°; p = 0.59) ROMs were similar in both groups. The C3–4 CDA group had significantly greater prevalence (90.9% vs 58.44%; p = 0.02) and higher severity grades (2.27 ± 0.3 vs 0.97 ± 0.99; p = 0.0001) of HO.

CONCLUSIONS

Although CDA at C3–4 was infrequent, the improved clinical outcomes of CDA were similar at C3–4 to that in the other subaxial levels of the cervical spine at the approximately 5-year follow-ups. In this Asian population, who had a propensity to have ossification of the posterior longitudinal ligament, there was more HO formation in patients who received CDA at the C3–4 level than in other subaxial levels of the cervical spine. While the type of artificial discs could have confounded the issue, future studies with more patients are required to corroborate the phenomenon.

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Letter to the Editor. Segmental mobility and heterotopic ossification after cervical arthroplasty

Junfeng Zeng, Hao Liu, and Yi Yang