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

2012 ◽  
Vol 16 (6) ◽  
pp. 594-600 ◽  
Author(s):  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Hsiao-Wen Tsai ◽  
Chin-Chu Ko ◽  
Li-Yu Fay ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Neck Disability Index ◽  
Long Term Effects ◽  
Antiinflammatory Drugs ◽  
Cervical Arthroplasty ◽  
Arm Pain ◽  
Bryan Disc ◽  
Level Group

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.

scholarly journals Postoperative nonsteroidal antiinflammatory drugs and the prevention of heterotopic ossification after cervical arthroplasty: analysis using CT and a minimum 2-year follow-up

2015 ◽  
Vol 22 (5) ◽  
pp. 447-453 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Hsuan-Kan Chang ◽  
Chin-Chu Ko ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Antiinflammatory Drugs ◽  
Cervical Arthroplasty ◽  
Arm Pain ◽  
Nsaid Group ◽  
Number Of Patients ◽  
Cox 2

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.

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

2012 ◽  
Vol 16 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Hsiao-Wen Tsai ◽  
Chin-Chu Ko ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Disc Herniation ◽  
Cervical Disc ◽  
Artificial Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Arm Pain ◽  
Estimated Blood Loss

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.

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

2012 ◽  
Vol 16 (6) ◽  
pp. 601-609 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Ching-Lan Wu ◽  
Chin-Chu Ko ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Neck Disability Index ◽  
Ct Scanning ◽  
Segmental Motion ◽  
Artificial Disc ◽  
Analog Scale ◽  
Cervical Arthroplasty ◽  
Neck Disability

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.

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

2016 ◽  
Vol 24 (5) ◽  
pp. 752-759 ◽  
Author(s):  
Peng-Yuan Chang ◽  
Hsuan-Kan Chang ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
...  
Keyword(s):  
Cervical Spine ◽  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Large Scale ◽  
Japanese Orthopaedic Association ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain

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.

Arthroplasty for cervical spondylotic myelopathy: similar results to patients with only radiculopathy at 3 years' follow-up

2014 ◽  
Vol 21 (3) ◽  
pp. 400-410 ◽  
Author(s):  
Li-Yu Fay ◽  
Wen-Cheng Huang ◽  
Jau-Ching Wu ◽  
Hsuan-Kan Chang ◽  
Tzu-Yun Tsai ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Heterotopic Ossification ◽  
Cervical Myelopathy ◽  
Cervical Spondylotic Myelopathy ◽  
Viable Option ◽  
Cervical Arthroplasty ◽  
Arm Pain ◽  
Significant Difference ◽  
The Mean

Object Cervical arthroplasty has been accepted as a viable option for surgical management of cervical spondylosis or degenerative disc disease (DDD). The best candidates for cervical arthroplasty are young patients who have radiculopathy caused by herniated disc with competent facet joints. However, it remains uncertain whether arthroplasty is equally effective for patients who have cervical myelopathy caused by DDD. The aim of this study was to compare the outcomes of arthroplasty for patients with cervical spondylotic myelopathy (CSM) and patients with radiculopathy without CSM. Methods A total of 151 consecutive cases involving patients with CSM or radiculopathy caused by DDD and who underwent one- or two-level cervical arthroplasty were included in this study. Clinical outcome evaluations and radiographic studies were reviewed. Clinical outcome measurements included the Visual Analog Scale (VAS) of neck and arm pain, Japanese Orthopaedic Association (JOA) scores, and the Neck Disability Index (NDI) in every patient. For patients with CSM, Nurick scores were recorded for evaluation of cervical myelopathy. Radiographic studies included lateral dynamic radiographs and CT for detection of the formation of heterotopic ossification . Results Of the 151 consecutive patients with cervical DDD, 125 (82.8%; 72 patients in the myelopathy group and 53 in the radiculopathy group) had at least 24 months of clinical and radiographic follow-up. The mean duration of follow-up in these patients was 36.4 months (range 24–56 months). There was no difference in sex distribution between the 2 groups. However, the mean age of the patients in the myelopathy group was approximately 6 years greater than that of the radiculopathy group (53.1 vs 47.2 years, p < 0.001). The mean operation time, mean estimated blood loss, and the percentage of patients prescribed perioperative analgesic agents were similar in both groups (p = 0.754, 0.652, and 0.113, respectively). There were significant improvements in VAS neck and arm pain, JOA scores, and NDI in both groups. Nurick scores in the myelopathy group also improved significantly after surgery. In radiographic evaluations, 92.5% of patients in the radiculopathy group and 95.8% of those in the radiculopathy group retained spinal motion (no significant difference). Evaluation of CT scans showed heterotopic ossification in 34 patients (47.2%) in the myelopathy group and 25 patients (47.1%) in the radiculopathy group (p = 0.995). At a mean of over 3 years postoperatively, no secondary surgery was reported in either group. Conclusions The severity of myelopathy improves after cervical arthroplasty in patients with CSM caused by DDD. At 3-year follow-up, the clinical and radiographic outcomes of cervical arthroplasty in DDD patients with CSM are similar to those patients who have only cervical radiculopathy. Therefore, cervical arthroplasty is a viable option for patients with CSM caused by DDD who require anterior surgery. However, comparison with the standard surgical treatment of anterior cervical discectomy and fusion is necessary to corroborate the outcomes of arthroplasty for CSM.

Prospective study of cervical arthroplasty in 98 patients involved in 1 of 3 separate investigational device exemption studies from a single investigational site with a minimum 2-year follow-up

2010 ◽  
Vol 13 (6) ◽  
pp. 715-721 ◽  
Author(s):  
Domagoj Coric ◽  
Joseph Cassis ◽  
John D. Carew ◽  
Margaret O. Boltes
Keyword(s):  
Clinical Outcomes ◽  
Clinical Success ◽  
Total Disc Replacement ◽  
Neck Disability Index ◽  
Self Report ◽  
Cervical Disc ◽  
Adjacent Level ◽  
Cervical Arthroplasty ◽  
Investigational Device Exemption

Object Cervical total disc replacement (TDR) was developed to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. To establish an evidence-based rationale for cervical TDR to serve as a viable alternative to ACDF, cervical arthroplasty must establish equivalent or superior clinical outcomes while maintaining motion. The authors report on 98 patients from a single investigational site involved in 3 separate prospective, randomized, controlled investigational device exemption multicenter trials comparing cervical arthroplasty to ACDF with a 2–6-year follow-up. Methods Patients with 1- and 2-level cervical disc disease producing radiculopathy and/or myelopathy were randomized prospectively under 3 separate investigational device exemption pivotal trials to undergo ACDF with plate or artificial disc placement. The 3 arthroplasty systems evaluated were the Bryan cervical disc, Kineflex/C disc, and Discover cervical disc. The patients were evaluated with pre- and postoperative serial neurological examinations, radiographs, and clinical outcome indices at 1, 3, 6, 12, 24, 36, 48, and 60 months. Results Ninety-eight patients were treated at the authors' single investigational site. Fifty-seven of these patients underwent cervical arthroplasty and 41 underwent ACDF. A minimum 24-month follow-up was available for 90 patients (92%; 53 in the combined arthroplasty group and 37 in the combined ACDF group) with a follow-up duration ranging from 24 to 67 months (mean 38 months). Clinical success, defined as a composite measure consisting of 5 separate components, was significantly higher in the combined arthroplasty group (85%) compared with the combined ACDF group (70%; p = 0.035). The Neck Disability Index and visual analog scale patient self-report measures were evaluated at 3–24-months follow-up, and all groups showed excellent clinical outcomes. All groups (Bryan, Kineflex/C, Discover, and ACDF) showed statistically significant improvement from the preoperative period to a minimum 2-year follow-up (p < 0.0001). Overall, angular motion was improved by 0.91° in the combined arthroplasty group and reduced by 7.8° in the combined ACDF group (p < 0.0001). In the ACDF group there was a fusion rate of 97% (36 of 37 cases). In the arthroplasty group there was a 5.6% incidence of bridging heterotopic ossification (3 cases). There were a total of 4 reoperations (7.5%) in the combined arthroplasty group with 1 (1.9%) at the adjacent level. There were 3 reoperations (8.1%) in the ACDF group, all at the adjacent level. Conclusions The prospective, intermediate-term (average follow-up > 3 years) results of cervical TDR at the authors' site are encouraging. Patients treated with the artificial discs showed significantly better clinical results, maintained motion at the treated level, and trended toward less adjacent-level disease.

Radiological and clinical outcomes of 3-level cervical disc arthroplasty

2020 ◽  
Vol 32 (2) ◽  
pp. 174-181 ◽  
Author(s):  
Hsuan-Kan Chang ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Li-Yu Fay ◽  
Chao-Hung Kuo ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Large Scale ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Estimated Blood Loss

OBJECTIVEOne- and two-level cervical disc arthroplasty (CDA) has been compared to anterior cervical discectomy and fusion (ACDF) in several large-scale, prospective, randomized trials that have demonstrated similar clinical outcomes. However, whether these results would be similar when treating 3-level disc herniation and/or spondylosis has remained unanswered. This study aimed to investigate the differences between 3-level CDA and ACDF.METHODSA series of 50 patients who underwent 3-level CDA at C3–7 was retrospectively reviewed and compared with another series of 50 patients (age- and sex-matched controls) who underwent ACDF at C3–7. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain, the modified Japanese Orthopaedic Association (mJOA) scale, and the Neck Disability Index (NDI). Radiological outcomes included range of motion (ROM) at the index levels. Every patient was evaluated by CT for the presence of fusion in the ACDF group. Also, complication profiles were investigated.RESULTSThe demographics and levels of distribution in both groups were very similar. During the follow-up period of 24 months, clinical outcomes improved (overall and respectively in each group) for both the CDA and ACDF patients when compared with the patients’ preoperative condition. There were essentially few differences between the two groups in terms of neck and arm pain VAS scores, mJOA scores, and NDI scores preoperatively and at 3, 6, 12, and 24 months postoperatively. After the 3-level surgery, the CDA group had an increased mean ROM of approximately 3.4°, at 25.2° ± 8.84°, compared to their preoperative ROM (21.8° ± 7.20°) (p = 0.001), whereas the ACDF group had little mobility (22.8° ± 5.90° before and 1.0° ± 1.28° after surgery; p < 0.001). The mean operative time, estimated blood loss, and complication profiles were similar for both groups.CONCLUSIONSIn this selectively matched retrospective study, clinical outcomes after 3-level CDA and ACDF were similar during the 2-year follow-up period. CDA not only successfully preserved but slightly increased the mobility at the 3 index levels. However, the safety and efficacy of 3-level CDA requires more long-term data for validatation.

scholarly journals Effects of smoking on cervical disc arthroplasty

2019 ◽  
Vol 30 (2) ◽  
pp. 168-174 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Chao-Hung Kuo ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
Henrich Cheng ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Smoking Status ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Smoking Group

OBJECTIVECigarette smoking can adversely affect bone fusion in patients who undergo anterior cervical discectomy and fusion. However, there is a paucity of data on smoking among patients who have undergone cervical disc arthroplasty (CDA). The present study aimed to compare the clinical and radiological outcomes of smokers to those of nonsmokers following CDA.METHODSThe authors retrospectively reviewed the records of consecutive patients who had undergone 1- or 2-level CDA for cervical disc herniation or spondylosis and had a minimum 2-year follow-up. All patients were grouped into a smoking group, which consisted of those who had consumed cigarettes within 6 months prior to the CDA surgery, or a nonsmoking group, which consisted of those who had not consumed cigarettes at all or within 6 months of the CDA. Clinical outcomes were evaluated according to the visual analog scale for neck and arm pain, Neck Disability Index, Japanese Orthopaedic Association Scale, and Nurick Scale at each time point of evaluation. Radiological outcomes were assessed using radiographs and CT for multiple parameters, including segmental range of motion (ROM), neutral lordotic curve, and presence of heterotopic ossification (HO).RESULTSA total of 109 patients completed at least 2 years of follow-up and were analyzed (mean follow-up 42.3 months). There were 89 patients in the nonsmoking group and 20 in the smoking group. The latter group was younger and predominantly male (both p < 0.05) compared to the nonsmoking group. The two groups had similar improvements in all clinical outcomes after CDA compared to preoperatively. Radiological evaluations were also very similar between the two groups, except for two factors. The smoking group had well-preserved segmental ROM after CDA at an average of 8.1° (both pre- and postoperation). However, while the nonsmoking group remained mobile, segmental ROM decreased significantly (8.2° to 6.9°, p < 0.05) after CDA. There was a trend toward more HO development in the nonsmoking group than in the smoking group, but the difference was without significance (59.6% vs 50.0%, p = 0.43).CONCLUSIONSDuring an average 3.5 years of follow-up after 1- and 2-level CDA, cigarette smokers and nonsmokers had similar improvements in clinical outcomes. Moreover, segmental mobility was slightly better preserved in smokers. Since smoking status did not negatively impact outcomes, CDA may be a reasonable option for selected patients who have smoked.

Single-Level Cervical Arthroplasty with a Keel-less Prosthesis: Results in a Series of 35 Patients Operated on for Soft Disk Herniation with a Minimum of 3 Years of Follow-Up

2021 ◽  
Author(s):  
Vito Stifano ◽  
Giovanni Stati ◽  
Carlo Giacobbo Scavo ◽  
Ettore Carpineta ◽  
Guglielmo Cacciotti ◽  
...  
Keyword(s):  
Neck Disability Index ◽  
Reoperation Rate ◽  
Adjacent Segment ◽  
Disk Herniation ◽  
Range Of Movement ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Arm Pain ◽  
Soft Disk

Abstract Background Cervical arthroplasty with artificial cervical disks has gained popularity as an alternative to anterior discectomy and fusion. The main advantages of disk arthroplasty include maintenance of the range of movement, restitution of disk height and spinal alignment, and reduction of adjacent segment degeneration (ASD). In this article, we aimed to assess the outcomes of the use of a keel-less prosthesis. Material and Methods We included all the patients who underwent single-level cervical arthroplasties with the Discocerv Cervidisc Evolution for “soft” disk herniation. Clinical assessment included Neck Disability Index (NDI) and visual analog scale (VAS) for neck and arm pain. Radiologic studies investigated the occurrence of ASD and system failure or subsidence. The reoperation rate was also recorded. Results The study included 35 patients (14 men and 21 women; mean age: 42.5 years; mean follow-up: 57.8 months). There was a significant decrease in VAS neck and VAS arm scores, which went from 7.2 and 6.9 preoperatively to 2.2 and 1.7 postoperatively, 2.2 and 1.6 at 6 months, 2.0 and 1.8 at 1 year, and 2.1 and 1.3 at the last follow-up, respectively. The mean NDI score was 58.0 preoperatively, 19.4 postoperatively, 17.0 at 6 months, 16.1 at 1 year, and 16.2 at the last follow-up. Radiologic studies revealed a preserved range of motion in 33 of 35 patients. No ASD occurred and no reoperation was required. Conclusions Cervical disk arthroplasty with a keel-less prosthesis can be a safe and effective alternative to fusion for degenerative disk disease in selected patients, with a possible reduction of ASD.

scholarly journals Cervical arthroplasty: what does the labeling say?

2017 ◽  
Vol 42 (2) ◽  
pp. E2 ◽  
Author(s):  
Mazda K. Turel ◽  
Mena G. Kerolus ◽  
Owoicho Adogwa ◽  
Vincent C. Traynelis
Keyword(s):  
Outcome Measures ◽  
Revision Surgery ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Specific Treatment ◽  
The United States ◽  
Cervical Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Level Group

OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

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