http://www.sciencedirect.com/science/article/pii/S1935981010000046
Initial clinical experience with a next-generation artificial disc for the treatment of symptomatic degenerative cervical radiculopathy
Original Research Article
SAS Journal, Volume 4, Issue 1, March 2010, Pages 9-15
Alejandro Reyes-Sanchez, Victor Miramontes, Luis M. Rosales Olivarez, Armando Alpizar Aquirre, Alfredo Ortega Quiroz, Baron Zarate-Kalfopulos
SAS Journal, Volume 4, Issue 1, March 2010, Pages 9-15
Alejandro Reyes-Sanchez, Victor Miramontes, Luis M. Rosales Olivarez, Armando Alpizar Aquirre, Alfredo Ortega Quiroz, Baron Zarate-Kalfopulos
Abstract
Background
A feasibility trial was conducted to evaluate the
initial safety and clinical use of a next-generation artificial cervical disc
(M6-C artificial cervical disc; Spinal Kinetics, Sunnyvale, CA) for the
treatment of patients with symptomatic degenerative cervical radiculopathy. A
standardized battery of validated outcome measures was utilized to assess
condition-specific functional impairment, pain severity, and quality of life.
Methods
Thirty-six consecutive patients were
implanted with the M6-C disc and complete clinical and radiographic outcomes
for 25 patients (mean age, 44.5 ± 10.1 years) with radiographically-confirmed
cervical disc disease and symptomatic radiculopathy unresponsive to
conservative medical management are included in this report. All patients had
disc-osteophyte complex causing neural compression and were treated with
discectomy and artificial cervical disc replacement at either single level (n =
12) or 2-levels (n = 13). Functional impairment was evaluated using the Neck
Disability Index (NDI). Evaluation of arm and neck pain severity utilized a
standard 11-point numeric scale, and health-related quality of life was
evaluated with the SF-36 Health Survey. Quantitative radiographic assessments
of intervertebral motion were performed using specialized motion analysis
software, QMA (Quantitative Motion Analysis; Medical Metrics, Houston, TX). All
outcome measures were evaluated pre-treatment and at 6 weeks, 3, 6, 12, and 24
months.
Results
The mean NDI score improved from 51.6 ±
11.3% pre-treatment to 27.9 ± 16.9% at 24 months, representing an approximate
46% improvement (P < .0001). The mean arm pain score improved from
6.9 ± 2.5 pre-treatment to 3.9 ± 3.1 at 24 months (43%, P = .0006). The
mean neck pain score improved from 7.8 ± 2.0 pre-treatment to 3.8 ± 3.0 at 24
months (51%, P < .0001). The mean PCS score of the SF-36 improved
from 34.8 ± 7.8 pre-treatment to 43.8 ± 9.3 by 24 months (26%, P =
.0006). Subgroup analyses found that patients treated at single level and those
with a shorter duration of symptoms showed better functional results. By 24
months, the mean range of motion (ROM) value at the treated level had returned
to approximately pretreatment levels (12.2° vs 11.1°). There were no serious
device-related adverse events, surgical re-interventions or radiographic evidence
of heterotopic ossification, device migration, or expulsion in this study
group.
Conclusions
These findings indicate substantial
clinical improvement for all function, pain, and quality of life outcomes in
addition to maintenance of ROM and increase in disc height at the treated
level(s). The findings also exhibit an acceptable safety profile, as indicated
by the absence of serious adverse events and reoperations following
arthroplasty with a next-generation artificial cervical disc replacement
device.
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