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  • Author or Editor: Francine W. Schranck x
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Matthew F. Gornet, J. Kenneth Burkus, Mark E. Shaffrey, Francine W. Schranck and Anne G. Copay

OBJECTIVE

Food and Drug Administration–approved investigational device exemption (IDE) studies have provided level I evidence supporting cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion (ACDF). Long-term CDA outcomes continue to be evaluated. Here, the authors present outcomes at 10 years postoperatively for the single-level CDA arm of an IDE study (postapproval study).

METHODS

The primary endpoint was overall success, a composite variable composed of five criteria: 1) Neck Disability Index score improvement ≥ 15 points; 2) maintenance or improvement in neurological status; 3) no decline in anterior or posterior functional spinal unit (FSU) height of more than 2 mm compared to 6 weeks postoperatively; 4) no serious adverse event (AE) caused by the implant or the implant and the surgical procedure; and 5) no additional surgery classified as a failure. Additional safety and effectiveness measures included numeric rating scales for neck pain and arm pain, SF-36 quality-of-life physical and mental components, patient satisfaction, range of motion, and AEs.

RESULTS

From the reported assessments at 7 years postoperatively to the 10-year postoperative follow-up, the scores for all patient-reported outcomes, rate of overall success (without FSU), and proportion of patients at least maintaining their neurological function remained stable for the CDA group. Nine patients had secondary surgery at the index level, increasing the secondary surgery cumulative rate from 6.6% to 10.3%. In that same time frame, four patients experienced a serious implant or implant/surgical procedure–related AE, for a 10-year cumulative rate of 7.8%. Seven patients had any second surgery at adjacent levels, for a 10-year cumulative rate of 13.8%. Average angular motion at both the index and adjacent levels was well maintained without creating hypermobility. Class IV heterotopic ossification increased from 1.2% at 2 years to 4.6% at 7 years and 9.0% at 10 years. Patient satisfaction was > 90% at 10 years.

CONCLUSIONS

CDA remained safe and effective out to 10 years postoperatively, with results comparable to 7-year outcomes and with high patient satisfaction.

Clinical trial registration no.: NCT00667459 (clinicaltrials.gov)

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Matthew F. Gornet, Todd H. Lanman, J. Kenneth Burkus, Randall F. Dryer, Jeffrey R. McConnell, Scott D. Hodges and Francine W. Schranck

OBJECTIVE

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) implant-related 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)

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Matthew F. Gornet, J. Kenneth Burkus, Randall F. Dryer, John H. Peloza, Francine W. Schranck and Anne G. Copay

OBJECTIVE

Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics’ Maverick total disc replacement.

METHODS

Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.

RESULTS

Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.

CONCLUSIONS

Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.

Clinical trial registration no.: NCT00635843 (clinicaltrials.gov)