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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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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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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.

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

OBJECT

The aim of this paper was to investigate the risk of recurrence of lumbar disc herniation (LDH) in patients with scoliosis who underwent microdiscectomy.

METHODS

A series of consecutive patients who underwent microdiscectomy for LDH was retrospectively reviewed. The inclusion criteria were young adults younger than 40 years who received microdiscectomy for symptomatic 1-level LDH. An exclusion criterion was any previous spinal surgery, including fusion or correction of scoliosis. The patients were divided into 2 groups: those with scoliosis and those without scoliosis. The demographic data in the 2 groups were similar. All medical records and clinical and radiological evaluations were reviewed.

RESULTS

A total of 58 patients who underwent 1-level microdiscectomy for LDH were analyzed. During the mean follow-up of 24.6 months, 6 patients (10.3%) experienced a recurrence of LDH with variable symptoms. The recurrence rate was significantly higher among the scoliosis group than the nonscoliosis group (33.3% vs 2.3%, p = 0.001). Furthermore, the recurrence-free interval in the scoliosis group was short.

CONCLUSIONS

Young adults (< 40 years) with uncorrected scoliosis are at higher risk of recurrent LDH after microdiscectomy.

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

OBJECT

Heterotopic ossification (HO) after cervical arthroplasty is not uncommon and may cause immobility of the disc. To prevent HO formation, study protocols of clinical trials for cervical arthroplasty undertaken by the US FDA included perioperative use of nonsteroidal antiinflammatory drugs (NSAIDs). However, there are few data supporting the use of NSAIDs to prevent HO after cervical arthroplasty. Therefore, this study aimed to evaluate the efficacy of NSAIDs in HO formation and clinical outcomes.

METHODS

Consecutive patients who underwent 1- or 2-level cervical arthroplasty with a minimum follow-up of 24 months were retrospectively reviewed. All patients were grouped into 1 of 2 groups, an NSAID group (those patients who had used NSAIDs postoperatively) and a non-NSAID group (those patients who had not used NSAIDs postoperatively). The formation of HO was detected and classified using CT in every patient. The incidence of HO formation, disc mobility, and clinical outcomes, including visual analog scale (VAS) scores of neck and arm pain, neck disability index (NDI) scores, and complications were compared between the two groups. Furthermore, a subgroup analysis of the patients in the NSAID group, comparing the selective cyclooxygenase (COX)-2 to nonselective COX-2 NSAID users, was also conducted for each of the above-mentioned parameters.

RESULTS

A total of 75 patients (mean age [± SD] 46.71 ± 9.94 years) with 107 operated levels were analyzed. The mean follow-up duration was 38.71 ± 9.55 months. There were no significant differences in age, sex, and levels of arthroplasty between the NSAID and non-NSAID groups. There was a nonsignificantly lower rate of HO formation in the NSAID group than the non-NSAID group (47.2% vs. 68.2%, respectively; p = 0.129). During follow-up, most of the arthroplasty levels remained mobile, with similar rates of immobile discs in the NSAID and non-NSAID groups (13.2% and 22.7%, respectively; p = 0.318). Furthermore, there was a nonsignificantly lower rate of HO formation in the selective COX-2 group than the nonselective COX-2 group (30.8% vs 52.5%, respectively; p = 0.213). The clinical outcomes, including VAS neck, VAS arm, and NDI scores at 24 months postoperatively, were all similar in the NSAID and non-NSAID groups, as well as the selective and nonselective COX-2 groups (all p > 0.05).

CONCLUSIONS

In this study there was a trend toward less HO formation and fewer immobile discs in patients who used postoperative NSAIDs after cervical arthroplasty than those who did not, but this trend did not reach statistical significance. Patients who used selective COX-2 NSAIDs had nonsignificantly less HO than those who used nonselective COX-2 NSAIDs. The clinical outcomes were not affected by the use of NSAIDs or the kinds of NSAIDs used (selective vs nonselective COX-2). However, the study was limited by the number of patients included, and the efficacy of NSAIDs in the prevention of HO after cervical arthroplasty may need further investigation to confirm these results.

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

OBJECTIVE

Many reports have successfully demonstrated that cervical disc arthroplasty (CDA) can preserve range of motion after 1- or 2-level discectomy. However, few studies have addressed the extent of changes in segmental mobility after CDA or their clinical correlations.

METHODS

Data from consecutive patients who underwent 1-level CDA were retrospectively reviewed. Indications for surgery were medically intractable degenerative disc disease and spondylosis. Clinical outcomes, including visual analog scale (VAS)–measured neck and arm pain, Neck Disability Index (NDI), and Japanese Orthopaedic Association (JOA) scores, were analyzed. Radiographic outcomes, including C2–7 Cobb angle, the difference between pre- and postoperative C2–7 Cobb angle (ΔC2–7 Cobb angle), sagittal vertical axis (SVA), the difference between pre- and postoperative SVA (ΔSVA), segmental range of motion (ROM), and the difference between pre- and postoperative ROM (ΔROM), were assessed for their association with clinical outcomes. All patients underwent CT scanning, by which the presence and severity of heterotopic ossification (HO) were determined during the follow-up.

RESULTS

A total of 50 patients (mean age 45.6 ± 9.33 years) underwent a 1-level CDA (Prestige LP disc) and were followed up for a mean duration of 27.7 ± 8.76 months. All clinical outcomes, including VAS, NDI, and JOA scores, improved significantly after surgery. Preoperative and postoperative ROM values were similar (mean 9.5° vs 9.0°, p > 0.05) at each indexed level. The mean changes in segmental mobility (ΔROM) were −0.5° ± 6.13°. Patients with increased segmental mobility after surgery (ΔROM > 0°) had a lower incidence of HO and HO that was less severe (p = 0.048) than those whose ΔROM was < 0°. Segmental mobility (ROM) was significantly lower in patients with higher HO grade (p = 0.012), but it did not affect the clinical outcomes. The preoperative and postoperative C2–7 Cobb angles and SVA remained similar. The postoperative C2–7 Cobb angles, SVA, ΔC2–7 Cobb angles, and ΔSVA were not correlated to clinical outcomes after CDA.

CONCLUSIONS

Segmental mobility (as reflected by the mean ROM) and overall cervical alignment (i.e., mean SVA and C2–7 Cobb angle) had no significant impact on clinical outcomes after 1-level CDA. Patients with increased segmental mobility (ΔROM > 0°) had significantly less HO and similarly improved clinical outcomes than those with decreased segmental mobility (ΔROM < 0°).