Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study.

Autor: Phillips FM; Midwest Orthopaedics at Rush University Medical Center, 1611 W Harrison St # 300, Chicago, IL 60612, USA. Electronic address: frank.phillips@rushortho.com., Coric D; Carolina Neurosurgery & Spine Associates, Atruim Health Musculoskeletal Institute, 225 Baldwin Ave, Charlotte, NC 28204, USA., Sasso R; Indiana Spine Group, 13225 N Meridian St, Carmel, IN 46032, USA., Lanman T; Lanman Spinal Neurosurgery, 450 N Roxbury Dr, Beverly Hills, CA 90210, USA., Lavelle W; Upstate Bone and Joint Center, 6620 Fly Rd, East Syracuse, NY 13057, USA., Blumenthal S; Center for Disc Replacement at TBI, 6020 West Parker Rd #200, Plano, TX 75093, USA., Lauryssen C; Central Texas Brain and Spine, PLLC, 2217 Park Bend Dr, Unit 400, Austin TX 78758, USA., Guyer R; Center for Disc Replacement at TBI, 6020 West Parker Rd #200, Plano, TX 75093, USA., Albert T; Hospital for Special Surgery, 535 East 70th St, New York, NY 10021, USA., Zigler J; Center for Disc Replacement at TBI, 6020 West Parker Rd #200, Plano, TX 75093, USA., Cammisa F; Hospital for Special Surgery, 535 East 70th St, New York, NY 10021, USA., Milam RA; OrthoCarolina, 2001 Randolph Rd, Charlotte, NC 28207, USA.
Jazyk: angličtina
Zdroj: The spine journal : official journal of the North American Spine Society [Spine J] 2021 Feb; Vol. 21 (2), pp. 239-252. Date of Electronic Publication: 2020 Oct 21.
DOI: 10.1016/j.spinee.2020.10.014
Abstrakt: Background Context: Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series.
Purpose: To evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy.
Study Design/setting: Prospective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial.
Patient Sample: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF.
Outcome Measures: Pain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months.
Methods: Using propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls).
Results: Both ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups.
Conclusions: M6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.
(Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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