6 research outputs found
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Comparison of Adverse Events Between Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion: A 10-year Follow-up.
BACKGROUND CONTEXT: Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.
PURPOSE: To investigate the 10 year follow-up adverse events rates between CDA and ACDF.
STUDY DESIGN/SETTING: The study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a post-approval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.
PATIENT SAMPLE: n=463 patients.
OUTCOME MEASURES: Adverse events comparison of CDA and ACDF from self-reported and physiologic measures.
METHODS: At each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.
RESULTS: A total of 242 patients received CDA and 221 patients received ACDF. At 10 years follow up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p = 0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, urogenital and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p = 0.012) and more spinal events at the index level (p = 0.006). The ACDF group had significantly more non-union events (p = 0.019), and non-union outcome pending (p = 0.034), adjacent level spinal events (p = 0.033), and events that fell into the other category (p = 0.015).
CONCLUSIONS: The cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well
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Wednesday, September 26, 2018 3:35 PM – 5:05 PM Preserving Spinal Motion: 84. Ten-year adverse events after randomization to BRYAN cervical disc arthroplasty versus anterior cervical discectomy and fusion
Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential benefit of an early return toward unrestricted activities. However, the long-term adverse events of arthroplasty are yet to be fully reported. A 10-year experience with the BRYAN disc arthroplasty trial provides the opportunity to report adverse events.
To investigate the adverse events rates between BRYAN CDA and ACDF.
Prospective, randomized multicenter IDE trial with surgeries performed between May 2002 and October 2004.
A total of 242 patients received BRYAN CDA (110=male, and 132=female) with a mean age 44.4 years; 221 patients received ACDF (113=male, and 108=female) with a mean age of 44.7 years.
Adverse events that occurred up to 10 years after the initial surgery.
A 10-year analysis of outcomes following FDA investigation of patients randomized to the BRYAN cervical disc arthroplasty versus fusion at a single level was performed. Patients were followed at regular intervals and adverse events associated with CDA and ACDF were recorded. Adverse events included: cancer, cardiovascular, carpal tunnel syndrome, death, dysphagia or dysphonia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, non-union, spinal events, other events, other pain and intraoperative vascular injury. "Other events" consisted of various events that did not fit into another category, such as rash, depression, or hypertension. Each adverse event was compared between groups for the cumulative rate up to 10 years. Time to event analysis with a log-rank test was used for analysis.
At up to 10 years of follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer (p=.860), cardiovascular (p=.653), death (p=.507), dysphonia/dysphagia (p=.341), gastrointestinal (p=.389), infection (p=.669), urogenital (p=.873), respiratory (p=.984), implant displacement/loosening (p=.200), implant malposition (p=0.179), neck and arm pain (p=.411), neurological (p=.888), other pain (p=.147), spinal events (p=.792), urogenital (p=0.873) and intraoperative vascular injury (p=.583). However, the cumulative rates were different between the CDA and ACDF groups for non-union (p=.019), other events (p=0.015) and trauma (p=0.012).
The cumulative rates of patients who had any adverse events were not different between BRYAN artificial cervical disc and the anterior cervical arthrodesis group. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.
BRYAN cervical disc (Approved for this indication)
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117. Ten-year BRYAN cervical disc arthroplasty: does change in angular motion have an effect on changes in patient-reported outcomes?
Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion with the added potential benefit of maintaining angular motion. The BRYAN cervical disc has been studied with over 10 years of data currently reported.
The purpose of the study was to report the correlation between change in range of motion (ROM) and change in patient-reported outcomes.
This was a prospective, randomized multicenter Investigational Device Exemption (IDE) trial with surgeries performed between May 2002 and October 2004. A 10-year analyses of patient-reported outcomes, using BRYAN cervical disc arthroplasty at a single level, was performed.
A total of 242 patients received BRYAN CDA (110=male, and 132=female).
Using Neck Disability Index (NDI), neck pain and arm pain scores and ROM to determine the correlation between change in ROM and change in patient-reported clinical outcomes.
Eligible patients were ≥21 years of age with symptomatic cervical disc disease who had failed conservative care for at least 6 weeks. We documented patients' preoperative and postoperative follow-ups completed at regular intervals; clinical outcomes (NDI, neck pain and arm pain); and ROM were used for analysis. A correlation analysis was done, between change in ROM from preoperative to postoperative (regular follow-ups) and change in clinical outcomes from preoperative to postoperative. The analysis was performed using the Pearson correlation coefficient.
A total of 242 patients received BRYAN CDA (110=male, and 132=female) with a mean age of 44.4 years. There was no significant difference in the mean of ROM from preoperative (6.54°) to 3-month postoperative (6.3°). However, the mean change of ROM, from preoperative to all visits after 3 months, was statistically significant throughout the follow-up at 10 years with the mean change of ROM at the 10-year follow-up being 2.1° and the mean of ROM being 8.69°. NDI, neck pain and arm pain scores improved significantly by 38.3, 54.3 and 58.1 (p <0.001, p <0.001, p <0.001), respectively at 10-year follow-up with the mean scores being (13, 20.9, 14.1), respectively at that follow-up visit. No meaningful correlation between change in ROM and change in patient reported outcomes was noticed at follow-ups.
The ROM did not change significantly; however, NDI, neck and arm pain scores improved significantly after 3 months postoperatively. ROM was maintained and clinical outcomes were further improved in the follow-ups. The change in range of motion had no effect on change in clinical outcomes. With 10 years of data, there was no meaningful correlation between change in range of motion and change in patient reported clinical outcomes with BRYAN cervical disc arthroplasty.
BRYAN cervical disc (Approved for this indication)
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Employment Status for the First Decade Following Randomization to Cervical Disc Arthroplasty Versus Fusion
An analysis of employment status data up to 10 years following the Federal Drug Administration (FDA) Investigational Device Exemption (IDE) randomized trial and extension as post-approval study comparing BRYAN cervical disc (Medtronic, Minneapolis, MN) arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF) was performed.
Ten-year experience with the BRYAN disc arthroplasty trial provides opportunity to report patient employment data.
The long-term consequences of arthroplasty remain incomplete, including the occurrence of occupational compromise.
Patients' employment status were measured at regular intervals in both groups up to 10 years.
The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups. In the investigational group, 49.2% returned to work at 6 weeks compared with 39.4% of the control group (P = 0.046). At 6 months and 2 years postoperatively, there was a similar likelihood of active employment in both groups. After 2 years at all time points, 10% drop-off seen in control group employment, but not in investigational group. At 10 years, 76.2% CDA patients were employed to 64.1% ACDF patients (P = 0.057). Preoperative variables influencing work status at 10 years following CDA included: preoperative work status, age, and SF-36 Mental Component Score (SF-36 MCS); whereas, no significant preoperative factor identified with ACDF. Time to return to work was influenced in both groups by preoperative work status; and in the ACDF group: reaching age 65 at 10-year visit, preoperative arm pain and NDI score had significant influences.
More patients returned to work at 6 weeks after CDA compared with ACDF, although there was no difference by 6 months. After 2 years, a nonsignificant trend toward higher employment rates in the arthroplasty group was evident, but this difference could not be validated due to the very high rate of loss of patients to the follow-up.
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The relationship between surgical site drains and reoperation for wound-related complications following posterior cervical spine surgery: a multicenter retrospective study.
OBJECTIVEUse of surgical site drains following posterior cervical spine surgery is variable, and its impact on outcomes remains controversial. Studies of drain use in the lumbar spine have suggested that drains are not associated with reduction of reoperations for wound infection or hematoma. There is a paucity of studies examining this relationship in the cervical spine, where hematomas and infections can have severe consequences. This study aims to examine the relationship between surgical site drains and reoperation for wound-related complications following posterior cervical spine surgery.METHODSThis study is a multicenter retrospective review of 1799 consecutive patients who underwent posterior cervical decompression with instrumentation at 4 tertiary care centers between 2004 and 2016. Demographic and perioperative data were analyzed for associations with drain placement and return to the operating room.RESULTSOf 1799 patients, 1180 (65.6%) had a drain placed. Multivariate logistic regression analysis identified history of diabetes (OR 1.37, p = 0.03) and total number of levels operated (OR 1.32, p \u3c 0.001) as independent predictors of drain placement. Rates of reoperation for any surgical site complication were not different between the drain and no-drain groups (4.07% vs 3.88%, p = 0.85). Similarly, rates of reoperation for surgical site infection (1.61% vs 2.58%, p = 0.16) and hematoma (0.68% vs 0.48%, p = 0.62) were not different between the drain and no-drain groups. However, after adjusting for history of diabetes and the number of operative levels, patients with drains had significantly lower odds of returning to the operating room for surgical site infection (OR 0.48, p = 0.04) but not for hematoma (OR 1.22, p = 0.77).CONCLUSIONSThis large study characterizes current practice patterns in the utilization of surgical site drains during posterior cervical decompression and instrumentation. Patients with drains placed did not have lower odds of returning to the operating room for postoperative hematoma. However, the authors\u27 data suggest that patients with drains may be less likely to return to the operating room for surgical site infection, although the absolute number of infections in the entire population was small, limiting the analysis