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Repair of the chronically injured human spinal cord

Michael G. Fehlings

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Vertebral body split fracture after a single-level cervical total disc replacement

Case report

Tsung-Hsi Tu, Jau-Ching Wu, Li-Yu Fay, Chin-Chu Ko, Wen-Cheng Huang, and Henrich Cheng

Cervical total disc replacement (TDR) is a viable option for the surgical treatment of degenerative disc disease. This 67-year-old nonsmoking male patient underwent single-level ProDisc-C cervical TDR at C5–6 without any intraoperative problem. His radicular pain improved and he had no neck pain immediately after the operation. However, on postoperative Day 3, a radiograph demonstrated a vertical split fracture of the C-5 vertebra. This fracture was managed conservatively, and 2 years postoperatively a follow-up CT scan demonstrated stable device position and fusion of the fracture. Although the linear fracture caused no neurological symptoms or device migration, the authors advocate prudence in selection and installation of keel-design prostheses, even in a single-level cervical TDR scenario.

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The effects of carpentry on heterotopic ossification and mobility in cervical arthroplasty: determination by computed tomography with a minimum 2-year follow-up

Clinical article

Tsung-Hsi Tu, Jau-Ching Wu, Wen-Cheng Huang, Ching-Lan Wu, Chin-Chu Ko, and Henrich Cheng

Object

Heterotopic ossification (HO) after cervical arthroplasty can limit the mobility of an artificial disc. In this study the authors used CT scanning to assess the formation of HO with the goal of investigating the correlation between the carpentry of arthroplasty, formation of HO, mobility, and clinical outcomes.

Methods

A retrospective review of medical records, radiological studies, and clinical evaluations was conducted for consecutive patients who underwent 1- or 2-level cervical arthroplasty with the Bryan disc. The patients underwent follow-up for more than 24 months. The formation of HO was assessed using CT scanning as the final determination. The perfectness of carpentry for each arthroplasty level was scrutinized using criteria composed of 2 parameters (postoperative shell kyphosis and inadequate endplate coverage). Levels were divided into the optimal carpentry group and the suboptimal carpentry group. Radiographic and clinical outcomes, including the visual analog scale and neck disability index, were compared between the groups.

Results

A total of 107 levels of Bryan discs were placed in 75 patients (mean age 46.71 ± 9.94 years) and were analyzed. There was a male predominance of 68.0% (51 men), and the mean follow-up duration was 38.56 ± 9.66 months. Heterotopic ossification was identified in 60 levels (56.1%) by CT scanning. Most cases of HO were low grade and did not correlate with the limitation in the segmental motion of the arthroplasty device. There were no significant differences in terms of age, sex, and number of arthroplasty levels between the optimal and the suboptimal carpentry groups. However, the suboptimal carpentry group had significantly more high-grade HO (≥ Grade 2) than the optimal carpentry group (13 levels [12.1%] vs 7 levels [6.5%], p = 0.027). There were also more immobile (range of motion < 3°) artificial discs in the suboptimal carpentry group than the optimal carpentry group (11 levels [10.3%] vs 4 levels [3.7%], p = 0.010). The clinical outcomes (neck and arm visual analog scale scores and Neck Disability Index) in both groups were similarly good.

Conclusions

Shell kyphosis and inadequate endplate coverage have adverse effects on the formation of HO and segmental mobility after cervical arthroplasty with the Bryan artificial disc. Appropriate carpentry is the more important factor in determining the maintenance of segmental motion. Although the midterm clinical outcome remained similarly good regardless of HO, the carpentry of cervical arthroplasty should not be overlooked. Further studies are needed to clarify the etiology of HO.

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Letter to the Editor: Complication avoidance in intradural extramedullary spinal tumors

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

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Differences between soft-disc herniation and spondylosis in cervical arthroplasty: CT-documented heterotopic ossification with minimum 2 years of follow-up

Clinical article

Jau-Ching Wu, Wen-Cheng Huang, Tsung-Hsi Tu, Hsiao-Wen Tsai, Chin-Chu Ko, Ching-Lan Wu, and Henrich Cheng

Object

Cervical arthroplasty is a valid option for patients with single-level symptomatic cervical disc diseases causing neural tissue compression, but postoperative heterotopic ossification (HO) can limit the mobility of an artificial disc. In the present study the authors used CT scanning to assess HO formation, and they investigated differences in radiological and clinical outcomes in patients with either a soft-disc herniation or spondylosis who underwent cervical arthroplasty.

Methods

Medical records, radiographs, and clinical evaluations of consecutive patients who underwent single-level cervical arthroplasty were reviewed. Arthroplasty was performed using the Bryan disc. The patients were divided into a soft-disc herniation group and a spondylosis group. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain and the Neck Disability Index (NDI), whereas HO grading was determined by studying CT scans. Radiological and clinical outcomes were analyzed, and the minimum follow-up duration was 24 months.

Results

Forty-seven consecutive patients underwent a single-level cervical arthroplasty. Forty patients (85.1%) had complete radiological evaluations and clinical follow-up of more than 2 years. Patients were divided into 1 of 2 groups: soft-disc herniation (16 cases) and the spondylosis group (24 cases). Their mean age was 45.51 ± 11.12 years. Sixteen patients (40%) were female. Patients in the soft-disc herniation group were younger than those in the spondylosis group, but the difference was not statistically significant (42.88 vs 47.26, p = 0.227). The mean follow-up duration was 38.83 ± 9.74 months. Sex, estimated blood loss, implant size, and perioperative NSAID prescription were not significantly different between the groups (p = 0.792, 0.267, 0.581, and 1.000, respectively). The soft-disc herniation group had significantly less HO formation than the spondylosis group (1 HO [6.25%] vs 14 Hos [58.33%], p = 0.001). Almost all artificial discs in both groups remained mobile (100% and 95.8%, p = 0.408). The clinical outcomes were not significantly different between the groups at all postoperative time points of evaluation, and clinical improvements were also similar.

Conclusions

Clinical outcomes of single-level cervical arthroplasty for soft-disc herniation and spondylosis were similar 3 years after surgery. There was a significantly higher rate of HO formation in patients with spondylosis than in those with a soft-disc herniation. The mobility of the artificial disc is maintained, but the long-term effects of HO and its higher frequency in spondylotic cases warrant further investigation.

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Editorial: Cervical arthroplasty

Beejal Y. Amin and Praveen V. Mummaneni

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Acidic fibroblast growth factor for repair of human spinal cord injury: a clinical trial

Clinical article

Jau-Ching Wu, Wen-Cheng Huang, Yu-Chun Chen, Tsung-Hsi Tu, Yun-An Tsai, Shih-Fong Huang, Hsueh-Chen Huang, and Henrich Cheng

Object

The study aimed to verify the safety and feasibility of applying acidic fibroblast growth factor (aFGF) with fibrin glue in combination with surgical neurolysis for nonacute spinal cord injury.

Methods

This open-label, prospective, uncontrolled human clinical trial recruited 60 patients with spinal cord injuries (30 cervical and 30 thoracolumbar). The mean patient age was 36.5 ± 15.33 (mean ± SD) years, and the male/female ratio was 3:1. The mean time from injury to treatment was 25.7 ± 26.58 months, and the cause of injury included motor vehicle accident (26 patients [43.3%]), fall from a height (17 patients [28.3%]), sports (4 patients [6.7%]), and other (13 patients [21.7%]). Application of aFGF with fibrin glue and duraplasty was performed via laminectomy, and an adjuvant booster of combined aFGF and fibrin glue (2 ml) was given at 3 and 6 months postsurgery via lumbar puncture. Outcome measurements included the American Spinal Injury Association (ASIA) motor scores, sensory scores, impairment scales, and neurological levels. Examination of functional independence measures, visual analog scale, MR imaging, electrophysiological and urodynamic studies, hematology and biochemistry tests, tumor markers, and serum inflammatory cytokines were all conducted. All adverse events were monitored and reported. Exclusions were based on refusal, unrelated adverse events, or failure to participate in the planned rehabilitation.

Results

Forty-nine patients (26 with cervical and 23 with thoracolumbar injuries) completed the 24-month trial. Compared with preoperative conditions, the 24-month postoperative ASIA motor scores improved significantly in the cervical group (from 27.6 ± 15.55 to 37.0 ± 19.93, p < 0.001) and thoracolumbar group (from 56.8 ± 9.21 to 60.7 ± 10.10, p < 0.001). The ASIA sensory scores also demonstrated significant improvement in light touch and pinprick in both groups: from 55.8 ± 24.89 to 59.8 ± 26.47 (p = 0.049) and 56.3 ± 23.36 to 62.3 ± 24.87 (p = 0.003), respectively, in the cervical group and from 75.7 ± 15.65 to 79.2 ± 15.81 (p < 0.001) and 78.2 ± 14.72 to 82.7 ± 16.60 (p < 0.001), respectively, in the thoracolumbar group. At 24-month follow-up, the ASIA impairment scale improved significantly in both groups (30% cervical [p = 0.011] and 30% thoracolumbar [p = 0.003]). There was also significant improvement in neurological level in the cervical (from 5.17 ± 1.60 to 6.27 ± 3.27, p = 0.022) and thoracolumbar (from 18.03 ± 4.19 to 18.67 ± 3.96, p = 0.001) groups. The average sum of motor items in functional independence measure also had significant improvement in both groups (p < 0.05). The walking/wheelchair locomotion subscale showed increased percentages of patients who were ambulatory (from 3.4% to 13.8% and from 17.9% to 35.7% in the cervical and thoracolumbar groups, respectively). There were no related adverse events.

Conclusions

The use of aFGF for spinal cord injury was safe and feasible in the present trial. There were significant improvements in ASIA motor and sensory scale scores, ASIA impairment scales, neurological levels, and functional independence measure at 24 months after treatment. Further large-scale, randomized, and controlled investigations are warranted to evaluate the efficacy and long-term results.

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Nerve repair using acidic fibroblast growth factor in human cervical spinal cord injury: a preliminary Phase I clinical study

Jau-Ching Wu, Wen-Cheng Huang, Yun-An Tsai, Yu-Chun Chen, and Henrich Cheng

Object

The aim of this study was to assess functional outcomes of nerve repair using acidic fibroblast growth factor (FGF) in patients with cervical spinal cord injury (SCI).

Methods

Nine patients who had cervical SCI for longer than 5 months were included in pre- and postoperative assessments of their neurological function. The assessments included evaluating activities of daily living, associated functional ability, and degree of spasticity, motor power, sensation, and pain perception. After the first set of assessments, the authors repaired the injured segment of the spinal cord using a total laminectomy followed by the application of fibrin glue containing acidic FGF. Clinical evaluations were conducted 1, 2, 3, 4, 5, and 6 months after the surgery. Preoperative versus postoperative differences in injury severity and grading of key muscle power and sensory points were calculated using the Wilcoxon signed-rank test.

Results

The preoperative degree of injury severity, as measured using the American Spinal Injury Association (ASIA) scoring system, showed that preoperative motor (52.4 ± 25.9 vs 68.6 ± 21.5), pinprick (61.0 ± 34.9 vs 71.6 ± 31.0), and light touch scores (57.3 ± 33.9 vs 71.9 ± 30.2) were significantly lower than the respective postoperative scores measured 6 months after surgery (p = 0.005, 0.012, and 0.008, respectively).

Conclusions

Based on the significant difference in ASIA motor and sensory scale scores between the preoperative status and the 6-month postoperative follow-up, this novel nerve repair strategy of using acidic FGF may have a role in the repair of human cervical SCI. Modest nerve regeneration occurred in all 9 patients after this procedure without any observed adverse effects. This repair strategy thus deserves further investigation, clinical consideration, and refinement.

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Differences between 1- and 2-level cervical arthroplasty: more heterotopic ossification in 2-level disc replacement

Clinical article

Jau-Ching Wu, Wen-Cheng Huang, Hsiao-Wen Tsai, Chin-Chu Ko, Li-Yu Fay, Tsung-Hsi Tu, Ching-Lan Wu, and Henrich Cheng

Object

The most currently accepted indication for cervical arthroplasty is 1- or 2-level degenerative disc disease (DDD) refractory to medical treatment. However, the randomized and controlled clinical trials by the US FDA investigational device exemption studies only compared cervical arthroplasty with anterior cervical discectomy and fusion for 1-level disease. Theoretically, 2-level cervical spondylosis usually implicates more advanced degeneration, whereas the 1-level DDD can be caused by merely a soft-disc herniation. This study aimed to investigate the differences between 1- and 2-level cervical arthroplasty.

Methods

The authors analyzed data obtained in 87 consecutive patients who underwent 1- or 2-level cervical arthroplasty with Bryan disc. The patients were divided into the 1-level and the 2-level treatment groups. Clinical outcomes were measured using the visual analog scale (VAS) for the neck and arm pain and the Neck Disability Index (NDI), with a minimum follow-up of 30 months. Radiographic outcomes were evaluated on both radiographs and CT scans.

Results

The study analyzed 98 levels of Bryan cervical arthroplasty in 70 patients (80.5%) who completed the evaluations in a mean follow-up period of 46.21 ± 9.85 months. There were 22 females (31.4%) and 48 males (68.6%), whose mean age was 46.57 ± 10.07 years at the time of surgery. The 1-level group had 42 patients (60.0%), while the 2-level group had 28 patients (40.0%). Patients in the 1-level group were younger than those in the 2-level group (mean 45.00 vs 48.93 years, p = 0.111 [not significant]). Proportional sex compositions and perioperative prescription of nonsteroidal antiinflammatory drugs were also similar in both groups (p = 0.227 and p = 1.000). The 2-level group had significantly greater EBL during surgery than the 1-level group (220.80 vs 111.89 ml, p = 0.024). Heterotopic ossification was identified more frequently in the 2-level group than the 1-level group (75.0% vs 40.5%, p = 0.009). Although most of the artificial discs remained mobile during the follow up, the 2-level group had fewer mobile discs (100% and 85.7%, p = 0.022) than the 1-level group. However, in both groups, the clinical outcomes measured by VAS for neck pain, VAS for arm pain, and NDI all significantly improved after surgery compared with that preoperatively, and there were no significant differences between the groups at any point of evaluation (that is, at 3, 6, 12, and 24 months after surgery).

Conclusions

Clinical outcomes of 1- and 2-level cervical arthroplasty were similar at 46 months after surgery, and patients in both groups had significantly improved compared with preoperative status. However, there was a significantly higher rate of heterotopic ossification formation and less mobility of the Bryan disc in patients who underwent 2-level arthroplasty. Although mobility to date has been maintained in the vast majority (94.3%) of patients, the long-term effects of heterotopic ossification warrant further investigation.

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Ossification of the posterior longitudinal ligament in the cervical spine: an 11-year comprehensive national epidemiology study

Jau-Ching Wu, Laura Liu, Yu-Chun Chen, Wen-Cheng Huang, Tzeng-Ji Chen, and Henrich Cheng

Object

This study aimed to calculate the incidence and prevalence of ossification of the posterior longitudinal ligament (OPLL) in the cervical spine with its comorbid disability.

Methods

Using an 11-year nationwide database in Taiwan (National Health Insurance Research Database), this retrospective study cohort analyzed the incidences of cervical OPLL causing hospitalization. All patients admitted for the diagnosis of OPLL, regardless of surgery, were identified. Age- and sex-specific incidences, Poisson regression, and multivariate logistic regression analysis were conducted.

Results

Between 1997 and 2007 covering 241,800,725.8 person-years, 1651 patients were admitted for OPLL. The overall incidence of OPLL-related admission was 6.1 per 1 million person-years. Specifically, male sex and older age were associated with higher OPLL incidences (both p < 0.001). Among the 1651 OPLL patients, 542 (32.8%) received conservative management, 612 (37.1%) had anterior only surgery, 353 (21.4%) had posterior only surgery, and 144 (8.7%) had anterior and posterior surgery. Eighty-five patients were moderately to severely disabled (5.2% cumulative incidence rate). The incidences of disability varied by age, in a decreasing trend, except for the 60- to 69-year-old age group (p = 0.05). Patients who received posterior-only surgery were more likely to have disability.

Conclusions

In a large cohort of the Chinese population, the incidence of cervical OPLL-related admission is 6.1 per 1 million person-years, and the prevalence rate is 7.7 per 100,000 person-years. Higher incidences are observed in elderly and male patients, which implies the disease's degenerative nature. After adjustments for demographics, the incidences and trends of OPLL-related comorbid disability are associated with age and surgical approaches.