Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial

被引：54

作者：

Garcia, Rolando, Jr. ^{[1
]}

Yue, James J. ^{[2
]}

Blumenthal, Scott ^{[3
]}

Coric, Dom ^{[4
]}

Patel, Vikas V. ^{[5
]}

Leary, Scott P. ^{[6
]}

Dinh, Dzung H. ^{[7
]}

Buttermann, Glenn R. ^{[8
]}

Deutsch, Harel ^{[9
]}

Girardi, Federico ^{[10
]}

Billys, James ^{[11
]}

Miller, Larry E. ^{[12
]}

机构：

[1] Orthoped Care Ctr, Worcester, MA USA

[2] Yale Univ, Sch Med, New Haven, CT 06520 USA

[3] Texas Back Inst, Plano, TX USA

[4] Carolina Neurosurg & Spine Associates, Charlotte, NC USA

[5] Univ Colorado, Anschutz Med Campus, Boulder, CO 80309 USA

[6] SENTA Clin & Scripps Hlth, San Diego, CA USA

[7] Illinois Neurol Inst, Peoria, IL USA

[8] Midwest Spine Inst, Stillwater, MN USA

[9] Rush Univ, Med Ctr, Chicago, IL USA

[10] Hosp Special Surg, London, England

[11] Florida Orthopaed Inst, Tampa, FL USA

[12] Miller Sci Consulting Inc, 1854 Hendersonville Rd,231, Asheville, NC 28803 USA

来源：

SPINE | 2015年 / 40卷 / 24期

关键词：

activL; artificial disc; back pain; degenerative disc disease; motion preservation; randomized controlled trial; total disc replacement; INVESTIGATIONAL DEVICE EXEMPTION; CHARITE(TM) ARTIFICIAL DISC; CIRCUMFERENTIAL FUSION; PRODISC-L; DISEASE;

D O I：

10.1097/BRS.0000000000001245

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

Study Design. A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial. Objective. The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy. Summary of Background Data. Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR. Methods. Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2: 1) to treatment with an investigational TDR device (activL (R), n = 218) or FDA-approved control TDR devices (ProDisc-L or Charite, n = 106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls. Results. The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P<0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P = 0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P<0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P = 0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P = 0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%). Conclusion. The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years.

引用

页码：1873 / 1881

页数：9

共 14 条

[1]

A prospective, randomized, multicenter food and drug administration Investigational device exemptions study of lumbar total disc replacement with the CHARITE™ artificial disc versus lumbar fusion Part I:: Evaluation of clinical outcomes [J].