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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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Michael G. Fehlings

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Jau-Ching Wu, Wen-Cheng Huang, Ming-Chao Huang, Yun-An Tsai, Yu-Chun Chen, Yang-Hsin Shih and Henrich Cheng

Object

In this study, the authors evaluated the efficacy of a new surgical strategy for reconnecting the injured brachial plexus with the spinal cord using fibrin glue containing acidic fibroblast growth factor as an adhesive and neurotrophic agent.

Methods

Eighteen patients with preganglionic brachial plexus injuries, each with varying degrees of upper limb dysfunction, underwent cervical laminectomy with or without sural nerve grafting. The treatment of each avulsed root varied according to the severity of the injury. Some patients also underwent a second-stage operation involving supraclavicular brachial plexus exploration for reconnection with the corresponding segment of cervical spinal cord at the trunk level. Muscle strength was graded both pre- and postoperatively with the British Medical Research Council scale, and the results were analyzed with the Friedman and Wilcoxon signed-rank tests.

Results

Muscle strength improvements were observed in 16 of the 18 patients after 24 months of follow-up. Significant improvements in mean muscle strength were observed in patients from all repair method groups at 12 and 24 months postoperatively (p < 0.05). Statistical significance was not reached in the groups with insufficient numbers of cases.

Conclusions

The authors' new surgical strategy yielded clinical improvement in muscle strength after preganglionic brachial plexus injury, such that nerve regeneration may have taken place. Reconnection of the brachial plexus to the cervical spinal cord is possible. Functional motor recovery, observed through increases in Medical Research Council–rated muscle strength in the affected arm, is likewise possible.

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Chin-Chu Ko, Hsiao-Wen Tsai, Wen-Cheng Huang, Jau-Ching Wu, Yu-Chun Chen, Yang-Hsin Shih, Hung-Chieh Chen, Ching-Lan Wu and Henrich Cheng

Object

Dynamic stabilization systems are used to stabilize degenerative lumbar spondylosis. Loosening of the pedicle screws in such nonfusion implants is predictable. This retrospective study evaluated the incidence of screw loosening and its effect on clinical outcomes.

Methods

Charts, radiographic films, and medical records of 71 consecutive patients who underwent decompression using Dynesys dynamic stabilization for 1- or 2-level lumbar spondylosis were reviewed. Radiographic films were evaluated and compared to detect screw loosening. A visual analog scale (VAS) for back pain and the Oswestry Disability Index (ODI) were used for measuring clinical outcome. Statistical analysis was conducted using the chisquare test and Student t-test.

Results

The 71 patients in the study sample had a mean age of 59.2 ± 11.65 years (range 23–80 years), with slight female predominance (39 women, 32 men). The mean follow-up duration was 16.6 months (range 8–29 months). There were loose screws in 14 of 71 patients (19.7%), for a rate of 4.6% per screw (17 of 368 screws). Most screw loosening occurred in patients ≥ 55 years old (13 of 14 patients) although age and sex had no effect on screw loosening (p = 0.233 and 0.109, respectively). Both the loose screw and solid screw groups experienced significant improvement after the surgery in VAS and ODI scores. On the VAS, scores improved from 5.9 ± 2.99 to 2.1 ± 2.14 in the loose screw group (p = 0.003), and from 5.7 ± 3.45 to 2.9 ± 2.68 in the solid screw group (p < 0.001). For the ODI scale, scores improved from 43.5 ± 16.78% to 28.0 ± 18.18% (p = 0.006) in the loose screw group, and from 52.1 ± 20.92% to 24.6 ± 19.78% (p < 0.001) in the solid screw group. There were no significant differences between the 2 groups (p = 0.334 for VAS, p = 0.567 for ODI).

Conclusions

The preliminary study of this pedicle-based dynamic stabilization device for 1- and 2-level lumbar spondylosis shows radiographic evidence of screw loosening in 19.7% of patients and 4.6% of screws. Nonetheless, the loosening of screws has no adverse effect on clinical improvement.

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Oral Presentations

2010 AANS Annual Meeting Philadelphia, Pennsylvania May 1–5, 2010

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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.

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Tsung-Hsi Tu, Jau-Ching Wu, Wen-Cheng Huang, Wan-Yuo Guo, Ching-Lan Wu, Yang-Hsin Shih and Henrich Cheng

Object

Heterotopic ossification (HO) after cervical total disc replacement (TDR) has been reported to impede artificial disc motion. In all previously reported cases of HO, assessment was based on plain radiographs. The authors hypothesized that CT scan is a more sensitive and accurate detector. The aims of this study were to assess the actual incidence of HO and its effect on outcome in a cohort of patients undergoing cervical TDR with the Bryan disc and to compare HO detection by means of plain radiographs and CT.

Methods

The authors retrospectively assessed data from medical records, radiological studies, and clinical evaluations of patients who underwent 1- or 2-level cervical TDR with the Bryan disc and were followed up for more than 12 months. The presence and grading of HO according to the McAfee classification were assessed by CT scan, and these findings were compared with findings on plain radiographs. Thirty-six patients (mean age 46.61 ± 7.24 years; range 29–60 years; 21 men and 15 women) who underwent Bryan TDR at 52 levels were included in the study. The mean duration of CT follow-up was 19.03 ± 4.64 months; the mean duration of clinical follow-up was 26.78 ± 7.20 months.

Results

On the basis of CT, HO was identified in 18 (50%) of 36 patients and 25 (48.1%) of 52 levels treated. Grade 1 HO was present in 9 of the levels treated (17.3%), Grade 2 in 13 levels (25.0%), Grade 3 in 2 levels (3.8%), and Grade 4 in 1 level (1.9%). Nineteen (76%) of the 25 affected levels were in patients who had undergone 2-level TDR. There was no significant association with patient sex or disc pathology. There was a tendency for HO development among older patients, but this finding was not statistically significant (mean age 48.8 ± 6.8 in patients with HO vs 44.4 ± 7.2 in those without HO, p = 0.065). Although HO was found in 25 levels, 96.2% of the treated levels (50 of 52) had segmental range of motion on dynamic (flexion and extension) radiographs. The concordance between HO grading by CT and radiography was high, with an intraclass correlation coefficient of 0.822 (lower limit of 95% CI: 0.710, p < 0.001). Patients who had HO had the same clinical success rate as those who did not (94.4% vs 94.4%, p = 1.00). The visual analog scale scores for neck and arm pain were significantly improved in both the HO and the non-HO group.

Conclusions

The rate of HO detected by CT scan in this cohort of patients undergoing cervical TDR with a Bryan disc was 48.1% per level treated and 50% per patient with minimal limitation of segmental motion (96.2% of levels remained mobile), but plain radiograph is an acceptable detection tool. Two-level surgery has a higher risk of HO, although development of HO does not affect clinical outcome.

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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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Michael G. Fehlings and Jefferson R. Wilson

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

Object

The long-term outcome of lumbar dynamic stabilization is uncertain. This study aimed to investigate the incidence, risk factors, and outcomes associated with screw loosening in a dynamic stabilization system.

Methods

The authors conducted a retrospective review of medical records, radiological studies, and clinical evaluations obtained in consecutive patients who underwent 1- or 2-level lumbar dynamic stabilization and were followed up for more than 24 months. Loosening of screws was determined on radiography and CT scanning. Radiographic and standardized clinical outcomes, including the visual analog scale (VAS) and Oswestry Disability Index (ODI) scores, were analyzed with a focus on cases in which screw loosening occurred.

Results

The authors analyzed 658 screws in 126 patients, including 54 women (42.9%) and 72 men (57.1%) (mean age 60.4 ± 11.8 years). During the mean clinical follow-up period of 37.0 ± 7.1 months, 31 screws (4.7%) in 25 patients (19.8%) were shown to have loosened. The mean age of patients with screw loosening was significantly higher than those without loosening (64.8 ± 8.8 vs 59.3 ± 12.2, respectively; p = 0.036). Patients with diabetes mellitus had a significantly higher rate of screw loosening compared with those without diabetes (36.0% vs 15.8%, respectively; p = 0.024). Diabetic patients with well-controlled serum glucose (HbA1c ≤ 8.0%) had a significantly lower chance of screw loosening than those without well-controlled serum glucose (28.6% vs 71.4%, respectively; p = 0.021). Of the 25 patients with screw loosening, 22 cases (88%) were identified within 6.6 months of surgery; 18 patients (72%) had the loosened screws in the inferior portion of the spinal construct, whereas 7 (28%) had screw loosening in the superior portion of the construct. The overall clinical outcomes at 3, 12, and 24 months, measured by VAS for back pain, VAS for leg pain, and ODI scores, were significantly improved after surgery compared with before surgery (all p < 0.05). There were no significant differences between the patients with and without screw loosening at all evaluation time points (all p > 0.05). All 25 patients with screw loosening were asymptomatic, and in 6 (24%) osseous integration was demonstrated on later follow-up. Also, there were 3 broken screws (2.38% in 126 patients or 0.46% in 658 screws). To date, none of these loosened or broken screws have required revision surgery.

Conclusions

Screw loosening in dynamic stabilization systems is not uncommon (4.7% screws in 19.8% patients). Patients of older age or those with diabetes have higher rates of screw loosening. Screw loosening can be asymptomatic and presents opportunity for osseous integration on later follow-up. Although adverse effects on clinical outcomes are rare, longer-term follow-up is required in cases in which screws become loose.