Single-level Cervical Disc Disease Research Articles

Complications in cervical total disc arthroplasty

Cervical total disc arthroplasty (CTDA) is an alternative to cervical fusion when addressing single level cervical disc disease and attempts to restore normal disc height and preserve motion, theoretically decreasing rates of adjacent segment disease (ASD) and symptomatic pseudoarthrosis. Although safe and effective, CTDA has a unique complication profile particularly in regard to long-term complications. Approach related complications are similar to anterior cervical discectomy and fusion (ACDF) and include injury to surrounding vascular, digestive, and neurologic structures. To achieve anatomic positioning, CTDA requires vertebral endplate cartilage removal and osseous preparation which can lead to endplate fracture, salvage fusion, or component malpositioning. Long term complications include heterotopic ossification (HO), implant subsidence, ASD requiring surgical intervention, and implant migration or translation. Although HO reduces motion at the prosthesis site, it does not appear to worsen clinical outcomes in most cases. Evidence is still conflicting regarding ASD when comparing ACDF to CTDA, however, the most recent evidence suggests a lower rate of development with CTDA.

A novel nanohydroxyapatite/polyamide-66 cage for reducing the subsidence rate after single-level anterior cervical discectomy and fusion: a comparative study of 7-year follow-up

BackgroundA novel nanohydroxyapatite/polyamide-66 cage (n-HA/PA66 cage) with a horseshoe shape was designed to lower the subsidence rate of the traditional hollow cylindrical n-HA/PA66 cage. However, no studies have compared the incidence of subsidence in the two cages. The purpose of this study was to compare the long-term clinical and radiological outcomes of the novel n-HA/PA66 cage with the hollow cylindrical n-HA/PA66 cage after anterior cervical discectomy and fusion (ACDF) to treat single-level cervical degenerative disk disease (CDDD).MethodsFifty-two patients with novel n-HA/PA66 cages (Group A) and fifty-five patients with hollow cylindrical n-HA/PA66 cages (Group B) were included. The radiological parameters included intervertebral height (IH), C2-7 angle (C2-7a), segmental alignment (SA), subsidence rate, and fusion rate. The clinical outcomes were visual analog scale (VAS) scores, Japanese Orthopedic Association (JOA) scores, and patient satisfaction rates.ResultsThe pre- and postoperative SA, C2-7a, and fusion rates of the patients in Groups A and B were similar. The preoperative and 6-month postoperative IHs in both groups were comparable. However, the final follow-up IH in Group B was significantly smaller than that in Group A (35.9 mm vs. 36.7 mm). The difference in the subsidence rates at the final follow-up between Group A (5.8%, 3/52) and Group B (18.2%, 10/55) was significant. The VAS score, JOA score, and patient satisfaction rate were not significantly different.ConclusionsThe novel n-HA/PA66 cage had similar favorable SA, C2-7a, fusion rate, and clinical outcomes compared to the hollow cylindrical n-HA/PA66 cage for treating single-level ACDF. Moreover, the novel n-HA/PA66 cage achieved a lower subsidence rate and higher IH than the hollow cylindrical n-HA/PA66 cage at the final follow-up.

Zero-profile implant versus integrated cage-plate implant in treatment of single level cervical disc disease.

The aim of this retrospective study is to evaluate and compare the clinical and radiological results of the use of Zero-P implant and the integrated cage-plate implant in surgical treatment of single level cervical disc disease. It includes 54 consecutive patients who underwent single level anterior cervical discectomy and fusion. The patients were divided into 2 groups. Group (A) including 28 patients operated with zero- profile implant and group (B) including 26 patients operated with integrated cage-plate implant. Mean operative time, blood loss, incidence of dysphagia and any other complications related to the procedure were recorded and compared. Patients were assessed radiologically by measuring cervical lordosis using the Cobb angle and the segmental angle. Patients were assessed clinically by the Japanese orthopedic association score and the neck disability index. These values were also compared. The mean age of the patients in group (A) was 49.5±11 years, and in group (B) it was 49.8±11.6 years. Mean blood loss and operative time in group (A) were 77.3±9.4 ml and 72.1±7.9 minutes, while in group B, they were 80.7±9.5 ml and 74.8±8.4 minutes with no statistically significant difference between both groups. There were also no statistically significant difference between both groups as regards incidence of dysphagia, clinical scores nor radiological parameters. In conclusion, both zero-profile implant and integrated cage-plate implant have comparable satisfactory clinical and radiological results in treatment of single level cervical disc diseases with little complications.

Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty: A Comparison of National Trends and Outcomes

Anterior cervical discectomy and fusion (ACDF) has been considered the standard treatment for degenerative cervical disc disease; however, recent trials have shown comparable outcomes with cervical disc arthroplasty (CDA). This study aimed to observe disparities in treatment paradigms of single-level cervical disc diseases and compare inpatient outcomes between procedures. A retrospective cohort of patients treated for single-level cervical disc herniation or degeneration without myelopathy was queried from the Nationwide Inpatient Sample spanning 2012-2015. Multivariate logistic regression was performed to assess the effects of demographics, temporality of admission, and hospital characteristics on odds of receiving CDA versus ACDF. Propensity-score matching was performed to compare cost, length of stay (LOS), non-home discharge, and inpatient complications. In total, 1028 CDAs and 44,374 ACDFs were performed for single-level cervical disc disease during 2012-2015. Matched comparison showed that while non-home discharges were not different between CDA and ACDF (P= 0.248), patients who received CDA had a 0.19-day shorter LOS (P < 0.001) and $4694 greater total cost (P < 0.001). There were no statistically significant differences in inpatient complication rates. Multivariate analysis showed that patients in the 26th-50th percentile, 51st-75th percentile, and 76th-100th percentile of median household income had greater odds of CDA compared with patients in the 0-25th percentile (odds ratio [OR] 1.35, P= 0.003; OR 1.31, P= 0.013; OR 1.34, P= 0.011, respectively). Patients with private insurance had greater odds of receiving CDA compared with patients on Medicare (OR 1.91, P < 0.001). CDA was associated with shorter LOS but greater costs compared with ACDF. Patients with greater median income and private insurance were more likely to receive CDA.

Outcome of Anterior Cervical Discectomy with PEEK Cage Fixation for Single Level Cervical Disc Disease

Objective: To assess the outcome of anterior cervical discectomy and fusion (ACDF) with PEEK cage.&#x0D; Material and Methods: This prospective study was conducted in the Departments of Neurosurgery Prime Teaching Hospital and Irfan General Hospital Peshawar. Patients undergoing one level ACDF with PEEK cage fixation were enrolled in the study. Patients who needed multiple level ACDF or corpectomy with plating and redo cases were excluded from the study. A proforma, which included age, gender, address, level of prolapsed disc, sign and symptoms, pain score, MRI findings were filled. All patients were assessed on day of discharge and on follow-up visit after one month. Data was analyzed with SPSS version 22.&#x0D; Results: Total 95 patients were included out of which 58 (61%) were male and 37 (39%) were female. Range of patients` Age was from 27 years to 64 years with 50.4 years mean age. Most patients (65%) had C6 radiculopathy. 58 patients (61%) had right sided radicular pain. 5 patients (5.26%) had radiculomyelopathy. C5 – C6 was the most common level operated (68 patients). Excellent results were achieved in 75 patients (79%) while satisfactory results in the rest of patients using Odom’s criteria. Bony fusion occurred in 92% of patients at 6 months.&#x0D; Conclusion: ACDF with PEEK cage fixation is a safe and beneficial procedure in one level cervical prolapse disc disease

STAND-ALONE PEEK CAGE FOR SINGLE LEVEL CERVICAL DISC DISEASE SHORT TERM RESULTS.

The Enthusiasm for Cervical cages in cervical fusion operations is an effort to avoid the morbidity associated with autogenous bone graft harvesting. The goal of the current study was to assess the reliability and efficacy of anterior cervical discectomy and fusion (ACDF) using a PEEK cage filled with hydroxyapatite granules in the treatment of single level disc affection. 19 patients affected by single-level cervical disc disease were included in this study. The clinical findings were assessed according to Odom’s criteria at last follow-up. Cervical spine segmental sagittal alignment was evaluated preoperative, direct postoperative and 12 months later. 19 patients underwent ACDF using a PEEK cervical cage. The clinical assessment according to Odom’s criteria after 12 months was excellent in 50%, good in 24% patients, fair in 11% and 15 poor clinical results. The mean segmental lordosis before surgery was 2°, corrected to - 6.6° immediately postoperative. The final mean segmental lordosis was 3.3°; the loss of correction was 3.5°. Anterior cervical discectomy and fusion using a stand-alone PEEK cage can be considered a safe and effective technique for the management of single level cervical disc disease.

Multilevel cervical arthroplasty-clinical and radiological outcomes.

Cervical disc arthroplasty (CDA) is a valid option for single-level cervical disc disease (CDD) as an alternative to fusion. However, the use in 3- and 4-level disc disease is under scrutiny with scarce data published so far. Our aim was to study clinical and radiological outcomes of arthroplasty in patients with multilevel CDD. Retrospective analysis of clinical records, pre- and post-operative neutral/dynamic X-rays of patients who underwent CDA in multilevel CDD (2-4 levels). We evaluated sagittal balance parameters (C2-7 and index angle, SVA), global and segmental range of motion (ROM)), neck and arm VAS, Odom's criteria, re-operation rate, adjacent segment disease (ASD), willingness to undertake the same procedure again. Rate of heterotopic ossification (HO) was studied for follow-up >2 years. A subgroup analysis was performed regarding 2-level versus 3- or 4-level arthroplasty. Thirty-two patients were included, 6 males and 26 females, mean age of 46 years (range, 30-63). Seventy-seven cervical disc levels were treated with the same artificial disc. Twenty-one patients were operated on 2 levels, nine in 3 levels, and 2 patients in 4 levels. Post-operatively, there was a decrease in SVA (-2.2±8.36 mm, P=0.098) and an increase in global (3.7±9.6º, P=0.042) and index (1.3±6.1º, P=0.071) ROM. Mean nVAS and aVAS decreased (7.5±1.1 to 2.5±1.5; 6.3±1.9 to 2.2±1.7, P<0.05). Two-level versus 3-4 level patient subgroups showed a lower SVA (-1.3±8.1 mm P=0.47; -3.4±6.3 mm P=0.107), a slight increase in global (1.6±9.4º P=0.44; 7.2±11.7º P=0.07) and index (1.1±4.7º P=0.12; 1.3±8.1º P=0.35) ROM. HO was present in 9.9% (7/71) of disc levels operated, none of them with grade 3 or 4. Multilevel CDA provides good clinical and radiological outcomes, preserving global and segmental cervical mobility, while having a beneficial effect on sagittal balance. These results hold for 2 to 4 levels, making this technique a valuable option in selected patients with cervical multilevel CDD.

Dynamic Cervical Implants (DCI) versus Anterior Cervical Discectomy and Fusion (ACDF) in Single-Level Cervical Disc Disease (CDD): Clinical and Radiographic Outcome

Background Data: In spite of being successful, anterior cervical discectomy and fusion ACDF has some complications, among them, pseudoarthrosis, implant failure, and adjacent level disease. Dynamic Cervical Implants (DCI) are motion-preserving implants started to take part in treating cervical spondylotic disease with promising results. Purpose: To compare the clinical and radiographic outcomes of ACDF versus DCI in patients with degenerativecervical radiculo- and/or myelopathy. Study Design: A prospective randomized controlled study. Patients and Methods: Forty patients with cervical spondylotic radiculo- and/or myelopathy were recruited for this study. They were 21 males and 19 females with mean age of 45±8.9 years. They were randomly allocated for either the ACDF group including 20 patients undergoing ACDF using PEEK cages or the DCI group including 20 patients using DCI. Clinical outcome parameters were brachialgia VAS and NDI, and radiological outcome parameters were fusion rate, adjacent level changes, and segmental mobility. Results: The mean follow-up was 20±4 months. The mean VAS of brachialgia decreased from 8.7 preoperatively to 6.6 postoperatively in ACDF group, while it decreased from 8.8 to 6.4 in DCI with no significant differences in both groups. The mean NDI improved from 24.7±1.6 to 16.2±1.8 in ACDF group and from 23.9±2.1 to 15.8±2.0 in DCI group, with no significant difference in both groups. Fusin rate was 100% in ACDF group. Radiologically, adjacent level changes were reported in 5 (25%) patients in ACDF group, while these changes were only observed in 1 patient (5%) of the DCI group. Segmental mobility was preserved in all patients in the DCI group but was lost in 3 patients at final follow-up visit. Conclusion: Although clinical outcomes of both ACDF and DCI groups were not significantly different at final follow-up, radiographic parameters were relatively better in DCI group compared to ACDF group including segmental mobility preservation and adjacent level changes. (2019ESJ198)

Motion analysis of dynamic cervical implant stabilization versus anterior discectomy and fusion: a retrospective analysis of 70 cases.

Retrospective kinematic analysis of treated level, adjacent levels, and overall cervical spine after single-level dynamic cervical implant (DCI) stabilization versus anterior cervical discectomy and fusion (ACDF). Between June 2009 and March 2013, 70 consecutive patients with a symptomatic single-level cervical degenerative disk disease (DDD) were enrolled in this study and divided into DCI (n = 35) group and ACDF (n = 35) group. All cases were followed up for more than 5years. The study compared perioperative parameters; clinical outcomes; and radiological parameters. Kinematic analysis included range of motion (ROM) of treated level and adjacent level, overall ROM (C2-C7), and changes in adjacent disk spaces. There were no significant differences between the DCI group and ACDF group in terms of improvement in the SF-36, VAS, NDI, and JOA scores. DCI stabilization resulted in better ROM of C2-C7 and the treated level than ACDF did. The ROM of treated level decreased significantly at 24months after surgery and last follow-up in the DCI group, and the C2-C7 ROM showed different degrees of reduction after the 24months after surgery. Radiological evidence of adjacent segment degeneration (ASD) at last follow-up was observed in 4/22 patients (18.2%) in the DCI group and 5/23 patients (21.7%) in the ACDF group which was not a significant difference between groups (p > 0.05). DCI stabilization for the treatment of cervical DDD cannot preserve the normal kinematics of the cervical spine for a long time, especially the treated level. DCI stabilization cannot decrease the risk of ASD compared with ACDF. These slides can be retrieved under Electronic Supplementary Material.

Wednesday, September 26, 2018 3:35 PM – 5:05 PM Preserving Spinal Motion: 88. Cervical artificial disc replacement with Prodisc-C: 10-year clinical and radiographic results of prospective observational study in a single institute

BACKGROUND CONTEXT Cervical artificial disc replacement (ADR) is indicated for the treatment of severe radiculopathy permitting neural decompression and maintenance of motion. Previous reports of short and mid-term results have shown that cervical ADR using Prodisc-C is safe and effective in symptomatic CDD between C3 and C7 PURPOSE The objective of this study is to evaluate long-term clinical and radiologic results of ADR using the Prodisc-C in patients with single-level cervical disc disease (CDD) in minimum 10-year follow-up. STUDY DESIGN/SETTING This study is a retrosepctive observational analyisis of prespective registry. PATIENT SAMPLE Data were collected through a prospective registry, with retrospective analysis performed on 79 consecutive patients treated with cervical ADR with the Prodisc-C device (DePuy Synthes, West Chester, PA, USA) in a single institution. OUTCOME MEASURES Clinical outcome measures included visual analog scale (VAS) for neck and arm pain and Owestry Disability Index (ODI). Serial flexion-extension cervical radiographs and CT scans were performed to assess range of motion (ROM) of index segment, adjacent segment degenerations (ASD), implant-related complications (migration, subsidence, lucency) and heterotopic ossification (HO) using McAfee classification system. METHODS All enrollees were evaluated pre- and postoperatively at regular intervals using both clinical and radiologic parameters. RESULTS Out of 79 patients enrolled, 79.7% (63/79) continued regular outpatient visits at the 5-year follow-up period. However, after 10 years, only 22.9% (17/71) of patients remained with the study. Average follow-up was 10.7 years. After 5-year follow-up, neck and arm pain improved 68.6% and 86.8%, respectively, and ODI had an improvement of 85.7%. However, after the last visit, neck pain improvement decreased to 29.7%, whereas arm pain and ODI remained at 74.6% and 68.9%, respectively. Neurologic success rate was 82.3% after final assessment. There were no episodes of device failure except one case of subsidence. Mean ROM of the device decreased from 6.7°at 5-year to 5.4°at final assessment. Radiographic ASD developed in 58.8% of patients (mild; 29.4%, moderate; 23.5%, severe; 5.8%, respectively) and 58.8% demonstrated HO at the final follow-up, however, only 17.6% were symptomatic requiring second surgery. CONCLUSIONS The Prodisc-C device for cervical ADR appears to be safe and effective for the treatment of CDD after long-term follow-up. Despite radiographic evidence of ASD and HO on final assessment, Prodisc-C ADR provided maintenance of segmental motion at the index level and good neurologic success rate. FDA DEVICE/DRUG STATUS Prodisc-C: FDA status unavailable from the author at press time.

Thursday, September 27, 2018 3:35 PM–5:05 PM Section on Motion Technology Abstract Presentations: 133. Cervical disc arthroplasty: 10-year results

BACKGROUND CONTEXT Level I evidence from FDA IDE studies of multiple devices supports cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion for appropriately selected patients. Long-term outcomes following CDA continue to be assessed. PURPOSE This reports the 10-year postoperative outcomes of CDA. STUDY DESIGN/SETTING Single-arm follow-up of the investigational group from a prospective, multicenter FDA IDE trial (postapproval study of clinicaltrials.gov: NCT00667459). PATIENT SAMPLE A total of 280 patients with single-level cervical disc disease with radiculopathy and/or myelopathy treated with CDA. OUTCOME MEASURES The primary endpoint was overall success, a composite variable that included five criteria: 1) Neck Disability Index (NDI) score improvement of ≥15 points; 2) maintenance or improvement in neurological status; 3) anterior nor posterior disc height declined by no more than 2 mm compared to 6-week postoperative; 4) no serious adverse event caused by the implant or by both the implant and surgical procedure; and 5) no additional surgery classified as failure. Additional safety and effectiveness endpoints included NDI, neck pain and arm pain numerical rating scales, SF-36, patient satisfaction, range of motion (ROM) and adverse events (AE). METHODS Clinical and radiographic assessments were performed preoperatively, intraoperatively, and postoperatively out to 10 years. RESULTS Follow up was 90.6% at 10 years; overall success rates (without disc height) remained stable at 74.3%. Preoperative, 7-year, and 10-year postoperative scores were as follows: NDI: 55.5±14.7, 15.1±19.8, 15.0±17.8; neck pain: 67.0±20.8, 12.0±22.1, 11.2±19.6; arm pain: 59.6±26.3, 8.8±18.0, 8.5±17.2; SF-36 PCS: 32.2±7.4, 45.6±11.7, 44.5±12.3, SF-36 MCS: 44.5±11.5, 52.9±9.7, 52.4±9.7. All improvements from preoperative to 7 and 10 years postoperative were statistically significant (p CONCLUSIONS CDA remained safe and effective out to 10 years postoperatively. Significant long-term patient-reported and neurological outcomes improvements from baseline were consistent with previous reports, with few additional serious AEs or secondary surgeries. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Outpatient anterior cervical discectomy: A French study and literature review.

In France, surgery for lumbar disc herniation is now being done in the outpatient ambulatory setting at select facilities. However, surgery for the cervical spine in this setting is controversial because of the dangers of neck hematoma. We wanted to share our experience with performing ambulatory anterior cervical discectomy in 30 patients at our facility. Since 2014, 30 patients (16 men, 14 women; mean age of 47.2 years) with cervical radiculopathy due to single-level cervical disc disease (19 at C5-C6 and 11 at C6-C7) were operated at our ambulatory surgery center. After anterior cervical discectomy, cervical disc replacement was performed in 13 patients and fusion in 17 patients. The mean operative time was 38minutes and the mean duration of postoperative monitoring was 7hours 30minutes. The patients stayed at the healthcare facility for an average of 10hours 10minutes. One female patient (3%) was transferred to a standard hospital unit due to a neurological deficit requiring surgical revision with no cause identified. Two patients (7%) were rehospitalized on Day 1 due to dysphagia that resolved spontaneously. Thus the "ambulatory success rate" was 90% (27/30). There were no other complications and the overall satisfaction rate was excellent (9.6/10). Outpatient anterior cervical discectomy is now widely performed in the United States. Ours is the first study of French patients undergoing this procedure. The complication rate was very low (<2%) and even lower than patients treated in an inpatient hospital setting in comparative studies. Note that our patients were carefully selected for outpatient surgery as certain risk factors for complications have previously been identified (age, 3+levels, comorbidities/ASA>2). No deaths in the first 30 days postoperative have been reported in the literature. Wound hematoma leading to airway compromise is rare in the ambulatory setting (0.2%). The few cases that occurred were detected early and the hematoma drained before the patient was discharged. Dysphagia is actually the most common complication (8 to 30%). Cervical spine surgery can be performed in an ambulatory surgery center in carefully selected patients. Our criteria are patients less than 65 years of age, single-level disease, ASA<2, and standard cervical morphology. The complication and readmission rates are low. Careful hemostasis combined with close postoperative monitoring for at least 6hours helps to reduce the risk of neck hematoma. Prevention of postoperative dysphagia must be a focus of the care provided.

Cervical Disk Replacement With Discover Versus Fusion in a Single-Level Cervical Disk Disease: A Prospective Single-Center Randomized Trial With a Minimum 2-Year Follow-up.

Prospective randomized study. To compare the clinical outcome after Discover arthroplasty versus anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical disk disease. ACDF is still the gold standard for surgical treatment of cervical spine degenerative disk disease. However, results of many studies suggest that it may cause degenerative changes at levels immediately above and below the fusion, known as adjacent segment degenerative disease. Cervical arthroplasty has recently been introduced as an alternative to standard procedure of ACDF. It showed decreased surgical morbidity, decreased complications from postoperative immobilization, and an earlier return to previous level of function. A total of 105 consecutive patients with single-level cervical disk disease, producing radiculopathy and/or myelopathy were randomly divided into groups to undergo ACDF or Discover arthroplasty. All patients were evaluated with preoperative and postoperative serial radiographic studies and clinically, using Neck Disability Index, Visual Analog Scale and neurological status at 3, 6, 12, and 24 months. The results of our study indicate that cervical arthroplasty using Discover Artificial Cervical Disc provides favorable clinical and radiologic outcomes in a follow-up period of 24 months. There has been significant improvement in clinical parameters, Visual Analog Scale and Neck Disability Index, at 3, 6, 12, and 24 months in arthroplasty group comparing to control group. The Discover artificial cervical disc replacement offers favorable outcome compared with ACDF for a single-level cervical disk disease at short-term and long-term follow-up.

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion\u2014a prospective, single-blinded, randomized, controlled multicenter study

PurposeStandard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion.MethodsThis multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level.ResultsThere was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty.ConclusionThe present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty.Trial registrationhttp://www.clinicaltrials.gov NCT 00735176.19.

Incidence and risk factors of axial symptoms after cervical disc arthroplasty: a minimum 5-year follow-up study.

BackgroundThe purpose of this study was to investigate whether uncovertebral joint ossification was a risk factor for axial symptoms (AS) after cervical disc arthroplasty (CDA).MethodsThis retrospective study included 52 consecutive patients who underwent CDA for single-level cervical disc disease. To examine possible risk factors for AS after CDA, univariate and multivariate logistic regression analyses were conducted to compare data from the patients with and without AS (the AS and no-AS groups, respectively).ResultsAmong the 52 patients examined, AS were observed in 24 patients (46.2 %), including a stiff neck (n = 11), neck pain and dullness (n = 10), and shoulder pain (n = 3). Uncovertebral joint ossification was detected in 22 (42.3 %) patients, including 17 patients in the AS group and 5 patients in the no-AS group. Clinical outcome improved during the follow-up period for the AS group. According to multivariate logistic regression analysis, uncovertebral joint ossification, cervical kyphosis, and range of motion (ROM) at the index level were identified as significant risk factors for AS after CDA.ConclusionsSatisfactory clinical outcomes were observed following CDA for the treatment of single-level cervical disc disease in the present cohort. In addition, uncovertebral joint ossification, cervical kyphosis, and ROM at the index level were found to affect the incidence of AS after CDA.

Long Term Societal Costs of Anterior Discectomy and Fusion (ACDF) versus Cervical Disc Arthroplasty (CDA) for Treatment of Cervical Radiculopathy.

Current literature suggests that anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have comparable clinical outcomes for the treatment of cervical radiculopathy. Given similar outcomes, an understanding of differences in long-term societal costs can help guide resource utilization. The purpose of this study was to compare the relative long-term societal costs of anterior cervical discectomy and fusion (ACDF) to cervical disc arthroplasty (CDA) for the treatment of single level cervical disc disease by considering upfront surgical costs, lost productivity, and risk of subsequent revision surgery. We completed an economic and decision analysis using a Markov model to evaluate the long-term societal costs of ACDF and CDA in a theoretical cohort of 45-65 year old patients with single level cervical disc disease who have failed nonoperative treatment. The long-term societal costs for a 45-year old patient undergoing ACDF are $31,178 while long-term costs for CDA are $24,119. Long-term costs for CDA remain less expensive throughout the modeled age range of 45 to 65 years old. Sensitivity analysis demonstrated that CDA remains less expensive than ACDF as long as annual reoperation rate remains below 10.5% annually. Based on current data, CDA has lower long-term societal costs than ACDF for patients 45-65 years old by a substantial margin. Given reported reoperation rates of 2.5% for CDA, it is the preferred treatment for cervical radiculopathy from an economic perspective.

Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes.

Cervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up. Prospective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months. Follow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p < 0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (≥15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1±11.9/8.2±12.3 points for CDA and 10.7±11.8/8.3±13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant- or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5°) and 84 (6.9°) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06±4.39/1.25±4.06 for CDA and (-0.23)±5.37/1.25±5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment. Prestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.

The Efficiency of Zero-profile Implant in Anterior Cervical Discectomy Fusion

A prospective controlled study. The aim of this study was to compare the safety and efficacy of the zero-profile device with that of an anterior cervical plate and cage in patients undergoing anterior cervical discectomy and fusion (ACDF). A series of studies have indicated that anterior instruments produce good clinical results during ACDF. However, common implants are associated with a high rate of postoperative complications. A cervical stand-alone cage with integrated fixation for zero-profile segmental stabilization has been developed to solve this problem. A total of 46 patients with cervical radiculopathy or myelopathy were randomly treated with an anterior plate and a cage or a new zero-profile implant between September 2009 and April 2010. Patients were followed for 2 years. The operation time, blood loss, exposure to radiation, the Japan Department of Orthopedics Association (JOA) score, pain Visual Analogue Score (VAS), and dysphagia score were recorded. The operation was completed successfully in 46 patients. Twenty-three patients received an anterior plate and cage (control group) and 23 patients received the new zero-profile implant (test group). Analysis of postoperative data at all protocol-defined intervals demonstrated improvement in all clinical outcomes for both the groups when compared with the corresponding preoperative data. No significant difference in VAS and JOA score was found in the 2 treatment groups. The test group had a greater reduction in dysphagia at all follow-up intervals, compared with the control group. No adjacent segment degeneration was found in the test group, whereas 4 patients in the control group developed degeneration in adjacent segments (P=0.045). Both the groups had no adverse events associated with the implant or implant surgery. The Zero-P implant is a viable alternative to ACDF in patients with persistently symptomatic, single-level cervical disk disease. The procedure requires more technical requirements than traditional plates.

Cervical Disc Arthroplasty with PRESTIGE LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes

Background Cervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige® LP Disc at 84-months follow up. Methods Prospective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months. Results Follow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p Conclusions Prestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.

The Neck Disability Index (NDI) and its correlation with quality of life and mental health measures among patients with single-level cervical disc disease scheduled for surgery.

The Neck Disability Index (NDI) is widely used as a self-rated disability score in patients with cervical radiculopathy. The purpose of this study was to evaluate whether the NDI score correlated with other assessments of quality of life and mental health in a specific group of patients with single-level cervical disc disease and corresponding radiculopathy. One hundred thirty-six patients were included in a prospective, randomized controlled clinical multicenter study on one-level anterior cervical discectomy with arthroplasty (ACDA) versus one-level anterior cervical discectomy with fusion (ACDF). The preoperative data were obtained at hospital admission 1 to 3 days prior to surgery. The NDI score was used as the dependent variable and correlation as well as regression analyses were conducted to assess the relationship with the short form-36, EuroQol-5Dimension-3 level and Hospital Anxiety and Depression Scale. The mean age at inclusion was 44.1 years (SD ±7.0, range 26-59 years), of which 46.3 % were male. Mean NDI score was 48.6 (SD = 12.3, minimum 30 and maximum 88). Simple linear regression analysis demonstrated a significant correlation between NDI and the EuroQol-5Dimension-3 level [R = -0.64, 95 % confidence interval (CI) -30.1- -19.8, p < 0.001] and to a lesser extent between NDI and the short form-36 physical component summary [R = -0.49, 95 % CI (-1.10- -0.58), p < 0.001] and the short form-36 mental component summary [R = -0.25, 95 % CI (-0.47- -0-09), p = 0.004]. Regarding NDI and the Hospital Anxiety and Depression Scale, a significant correlation for depression was found [R = 0.26, 95 % CI (0.21-1.73), p = 0.01]. Multiple linear regression analysis showed a statistically significant and the strongest correlation between NDI and the independent variables in the following order: EuroQol-5Dimension-3 level [R = -0.64, 95 % CI (-23.5- -7.9), p <0.001], short form-36 physical component summary [R = -0.41, 95 % CI (-0.93- -0.23), p = 0.001] and short form-36 mental component summary [R = -0.36, 95 % CI (-0.53- -0.15), p = 0.001]. The results from the present study show that the NDI correlated significantly with a different quality of life and mental health measures among patients with single-level cervical disc disease and corresponding radiculopathy.