Comparison of clinical outcomes between cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of single-level cervical spondylosis: a 10-year follow-up study

The Spine Journal 23 (2023) 361−368

The theoretical advantage of cervical disc arthroplasty includes preserved motion at the cervical level, which may reduce degeneration of the adjacent segments. The long-term follow-up results are still controversial.

PURPOSE: The present study aimed to retrospectively study the long-term efficacy and complications of cervical disc arthroplasty using a single commercially-available device in a single center.

STUDY DESIGN: This was a propensity-score matched cohort study.

PATIENT SAMPLE: This study enrolled 148 single-level cervical degenerative disease patients from January 2009 to March 2012. After 1:1 propensity score matching, 39 patients remained in the ACDF or ACDR groups.

OUTCOME MEASURES: The outcome measures were neurological functions (Neck Disability Index (NDI) and Japan Orthopedic Association (JOA) scores), radiographic evaluations (cervical curvature, operative segment range of motion, degenerative condition of adjacent segments, heterotopic ossification (HO) of the surgical segment), and complications.

METHODS: NDI and JOA scores were used to evaluate patient neurological functions. Cervical curvature (C2-C7 Cobb angle) and operative segment range of motion (ROM) were compared between the two groups. Grading criteria for osteophyte formation were used to evaluate the degenerative condition of adjacent segments. HO after ACDR was graded according to the McAfee grading method.

RESULTS: The average follow-up time was 119.3 §17.2 months. Satisfactory improvements in neurological function were obtained for both the ACDR and ACDF groups. There were no significant differences in VAS or NDI scores between the two groups. In the ACDR group, the ROM of the operative segment increased from 6.7 §4.3˚ before the operation to 8.9 §3.5˚ on the second day after the operation (p<.001). The ROM of the operative segment was 8.1 §4.0˚ at the 1-year follow-up, 7.2 §3.6˚ at the 2-year follow-up, 5.7 §4.5˚ at the 5-year follow-up and 4.3 §3.9˚ at the last follow-up. ASD was more likely to develop in the caudal adjacent segments and progressed with the follow-up time. At the last follow-up, HO was present in 27 patients (69.23%), while high-grade HO (McAfee scores III and IV) was detected in 6 patients (15.38%).

CONCLUSIONS: Through nearly 10 years of follow-up, ACDR was as effective as ACDF for treating single-level degenerative cervical disc disease. However, HO and the role of ACDR in the protection of ASD remains to be further observed and followed up.

Longitudinal assessment of segmental motion of the cervical spine following total disc arthroplasty: a comparative analysis of devices

J Neurosurg Spine 37:556–562, 2022

Total disc arthroplasty (TDA) has been shown to be an effective and safe treatment for cervical degenerative disc disease at short- and midterm follow-up. However, there remains a paucity of literature reporting the differences between individual prosthesis designs with regard to device performance. In this study, the authors evaluated the longterm maintenance of segmental range of motion (ROM) at the operative cervical level across a diverse range of TDA devices.

METHODS In this study, the authors retrospectively evaluated all consecutive patients who underwent 1- or 2-level cervical TDA between 2005 and 2020 at a single institution. Patients with a minimum of 6 months of follow-up and lateral flexion/extension radiographs preoperatively, 2 months postoperatively, and at final follow-up were included. Radiographic measurements included static segmental lordosis, segmental range of motion (ROM) on flexion/extension, global cervical (C2–7) ROM on flexion/extension, and disc space height. The paired t-test was used to evaluate improvement in radiographic parameters. Subanalysis between devices was performed using one-way ANCOVA. Significance was determined at p < 0.05.

RESULTS A total of 85 patients (100 discs) were included, with a mean patient age of 46.01 ± 8.82 years and followup of 43.56 ± 39.36 months. Implantations included 22 (22.00%) M6-C, 51 (51.00%) Mobi-C, 14 (14.00%) PCM, and 13 (13.00%) ProDisc-C devices. There were no differences in baseline radiographic parameters between groups. At 2 months postoperatively, PCM provided significantly less segmental lordosis (p = 0.037) and segmental ROM (p = 0.039). At final follow-up, segmental ROM with both the PCM and ProDisc-C devices was significantly less than that with the M6-C and Mobi-C devices (p = 0.015). From preoperatively to 2 months postoperatively, PCM implantation led to a significant loss of lordosis (p < 0.001) and segmental ROM (p = 0.005) relative to the other devices. Moreover, a significantly greater decline in segmental ROM from 2 months postoperatively to final follow-up was seen with ProDiscC, while segmental ROM increased significantly over time with Mobi-C (p = 0.049).

CONCLUSIONS Analysis by TDA device brand demonstrated that motion preservation differs depending on disc design. Certain devices, including M6-C and Mobi-C, improve ROM on flexion/extension from preoperatively to postoperatively and continue to increase slightly at final follow-up. On the other hand, devices such as PCM and ProDisc-C contributed to greater segmental stiffness, with a gradual decline in ROM seen with ProDisc-C. Further studies are needed to understand how much segmental ROM is ideal after TDA for preservation of physiological cervical kinematics.

 

Failure in cervical total disc arthroplasty

The Spine Journal 22 (2022) 353−369

Cervical total disc arthroplasty (TDA) is an alternative procedure to anterior cervical discectomy and fusion that facilitates neural decompression while both preserving motion of the spinal unit and decreasing the risk for degenerative changes at adjacent segments. However, due to its more recent introduction in clinical practice and low complication rates, the modes by which TDA may fail remain to be described.

PURPOSE: This study sought to identify the modes and frequencies of cervical TDA failure in order to propose a novel classification system.

STUDY DESIGN: Retrospective cohort and systematic review.

PATIENT SAMPLE: Patients who underwent single or two-level TDA for cervical radiculopathy or myelopathy at a single institution and in the literature of medium and large prospective studies. OUTCOME MEASURES: Cervical TDA failure, defined as subsequent surgical intervention at the index segment.

METHODS: This study retrospectively reviewed patients who underwent single or two-level TDA for cervical radiculopathy or myelopathy at a single institution to identify the potential implant failure modes. A systematic review and meta-analysis of prospective data in the literature was then performed to further supplement failure mode identification and to describe the rates at which the various failure types occurred. Statistical analysis included betweengroup comparisons of Non-Failed and Failed patients and frequencies of each failure type among Failed patients.

RESULTS: A retrospective review at our institution of 169 patients (201 levels) identified eight failures, for a failure rate of 4.7%. Additionally, seven patients were revised who had the primary surgery at an outside institution. The systematic review of 3976 patients (4525 levels) identified 165 (4.1%) additional failures. Using this data, six primary failure types were classified, with several subtypes. These include recurrent or persistent index-level stenosis (Type I); migration (Type II) presenting as gross extrusion (A) or endplate failure with subsidence/acute fracture (B); instability (Type III) due to mechanical loosening (A), septic loosening (B), or device fracture (C); device motion loss (Type IV) such as “locking” of the device in kyphosis; implantation error (Type V) due to malposition (A) or improper sizing (B); and wear (Type VI) either without osteolysis (A) or with wear-particle-induced osteolysis (B). Stenosis (Type I) was the most common mode of failure found both through retrospective review and in the literature.

CONCLUSIONS: Cervical TDA fails through six primary mechanisms. While rates of certain failures requiring subsequent surgical intervention are low, it is possible that these complications may become more prevalent upon further longitudinal observation. Thus, future application and validation of this classification system is warranted to evaluate how failure frequencies change over time and with larger patient samples. © 2021 Elsevier Inc. All rights reserved.

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial

Neurosurgery 88:497–505, 2021

Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration.

OBJECTIVE: To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology.

METHODS: This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C ®  Cervical Disc (Zimmer Biomet).  Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr.

RESULTS: At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr.

CONCLUSION: Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C ® continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

 

The Effect of T1-Slope in Spinal Parameters After Cervical Disc Arthroplasty

Neurosurgery 2020 DOI:10.1093/neuros/nyaa271

Although patients with cervical kyphosis are not ideal candidates for cervical disc arthroplasty (CDA), there is a paucity of data on patients with a straight or slightly lordotic neck.

OBJECTIVE: To correlate cervical lordosis, T1-slope, and clinical outcomes of CDA.

METHODS: The study retrospectively analyzed 95 patients who underwent 1-level CDA and had 2-yr follow-up. They were divided into a high T1-slope (≥28◦) group (HTSG,n=45) and a low T1-slope (<28◦) group (LTSG, n = 50). Cervical spinal alignment parameters, including T1-slope, cervical lordosis (C2-7 Cobb angle), and segmental mobility (range of motion [ROM]) at the indexed level, were compared. The clinical outcomes were also assessed.

RESULTS: The mean T1-slope was 28.1 ± 7.0◦. After CDA, the pre- and postoperative segmental motility remained similar and cervical lordosis was preserved. All the clinical outcomes improved after CDA. The HTSG were similar to the LTSG in age, sex, segmental mobility, and clinical outcomes. However, the HTSG had higher cervical lordosis than the LTSG. Furthermore, the LTSG had increased cervical lordosis (C2-7 Cobb angle), whereas the HTSG had decreased lordosis after CDA. Patients of the LTSG, who had more improvement in cervical lordosis, had a trend toward increasing segmental mobility at the index level (ROM) than the HTSG.

CONCLUSION: In this series, T1-slope correlated well with global cervical lordosis but did not affect the segmental mobility. After CDA, the changes in cervical lordosis correlated with changes in segmental mobility. Therefore, segmental lordosis should be cautiously preserved during CDA as it could determine the mobility of the disc.

Heterotopic ossification and radiographic adjacent-segment disease after cervical disc arthroplasty

J Neurosurg Spine 31:660–669, 2019

Cervical disc arthroplasty (CDA) is an accepted motion-sparing technique associated with favorable patient outcomes. However, heterotopic ossification (HO) and adjacent-segment degeneration are poorly understood adverse events that can be observed after CDA. The purpose of this study was to retrospectively examine 1) the effect of the residual exposed endplate (REE) on HO, and 2) identify risk factors predicting radiographic adjacent-segment disease (rASD) in a consecutive cohort of CDA patients.

METHODS A retrospective cohort study was performed on consecutive adult patients (≥ 18 years) who underwent 1- or 2-level CDA at the University of Calgary between 2002 and 2015 with > 1-year follow-up. REE was calculated by subtracting the anteroposterior (AP) diameter of the arthroplasty device from the native AP endplate diameter measured on lateral radiographs. HO was graded using the McAfee classification (low grade, 0–2; high grade, 3 and 4). Change in AP endplate diameter over time was measured at the index and adjacent levels to indicate progressive rASD.

RESULTS Forty-five patients (58 levels) underwent CDA during the study period. The mean age was 46 years (SD 10 years). Twenty-six patients (58%) were male. The median follow-up was 29 months (IQR 42 months). Thirty-three patients (73%) underwent 1-level CDA. High-grade HO developed at 19 levels (33%). The mean REE was 2.4 mm in the high-grade HO group and 1.6 mm in the low-grade HO group (p = 0.02). On multivariable analysis, patients with REE > 2 mm had a 4.5-times-higher odds of developing high-grade HO (p = 0.02) than patients with REE ≤ 2 mm. No significant relationship was observed between the type of artificial disc and the development of high-grade HO (p = 0.1). RASD was more likely to develop in the lower cervical spine (p = 0.001) and increased with time (p < 0.001). The presence of an artificial disc was highly protective against degenerative changes at the index level of operation (p < 0.001) but did not influence degeneration in the adjacent segments.

CONCLUSIONS In patients undergoing CDA, high-grade HO was predicted by REE. Therefore, maximizing the implant-endplate interface may help to reduce high-grade HO and preserve motion. RASD increases in an obligatory manner following CDA and is highly linked to specific levels (e.g., C6–7) rather than the presence or absence of an adjacent arthroplasty device. The presence of an artificial disc is, however, protective against further degenerative change at the index level of operation.

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

J Neurosurg Spine 31:508–518, 2019

The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).

METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.

RESULTS From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implantrelated or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%).

CONCLUSIONS The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

Effects of smoking on cervical disc arthroplasty

J Neurosurg Spine 30:168–174, 2019

Cigarette 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.

METHODS The 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).

RESULTS A 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).

CONCLUSIONS During 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.

Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels

J Neurosurg Spine 27:7–19, 2017

The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).

METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations.

RESULTS At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure–related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure–related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] -1.19 [-2.29 to -0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR -1.29 [95% BCI -2.12 to -0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months.

CONCLUSIONS The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion.

Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months

J Neurosurg Spine 26:653–667, 2017

The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels.

METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Efficacy and safety outcomes were measured according to the Neck Disability Index (NDI), Numeric Rating Scales for neck and arm pain, 36-Item Short-Form Health Survey (SF-36), gait abnormality, disc height, range of motion (investigational) or fusion (control), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all 4 of the following criteria were met: 1) NDI score improvement of ≥ 15 points over the preoperative score, 2) maintenance or improvement in neurological status compared with preoperatively, 3) no serious AE caused by the implant or by the implant and surgical procedure, and 4) no additional surgery (supplemental fixation, revision, or nonelective implant removal). Independent statisticians performed Bayesian statistical analyses.

RESULTS The 24-month rates of overall success were 81.4% for the investigational group and 69.4% for the control group. The posterior mean for overall success in the investigational group exceeded that in the control group by 0.112 (95% highest posterior density interval = 0.023 to 0.201) with a posterior probability of 1 for noninferiority and 0.993 for superiority, demonstrating the superiority of the investigational group for overall success. Noninferiority of the investigational group was demonstrated for all individual components of overall success and individual effectiveness end points, except for the SF-36 Mental Component Summary. The investigational group was superior to the control group for NDI success. The proportion of patients experiencing any AE was 93.3% (195/209) in the investigational group and 92.0% (173/188) in the control group, which were not statistically different. The rate of patients who reported any serious AE (Grade 3 or 4) was significantly higher in the control group (90 [47.9%] of 188) than in the investigational group (72 [34.4%] of 209) with a posterior probability of superiority of 0.996. Radiographic success was achieved in 51.0% (100/196) of the investigational patients (maintenance of motion without evidence of bridging bone) and 82.1% (119/145) of the control patients (fusion). At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients.

CONCLUSIONS Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

 

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion

J Neurosurg Spine 23:558–573, 2015

This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF).

METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings.

RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01–0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability.

CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.