Abstract
BACKGROUND
Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical
radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as
compared with anterior cervical discectomy and fusion (ACDF). Prior reports suggest
that ACDF is not more effective than anterior cervical discectomy (ACD) alone for
the treatment of cervical radiculopathy.
PURPOSE
To evaluate whether patients with cervical radiculopathy due to a herniated disc benefit
more from undergoing ACDA, ACDF, or ACD in terms of clinical outcome measured by the
neck disability index (NDI).
STUDY DESIGN
Double-blinded randomized controlled trial.
METHODS
One hundred-nine patients with one level herniated disc were randomized to one of
the following treatments: ACDA, ACDF with intervertebral cage, ACD without fusion.
Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS)
neck pain, VAS arm pain, SF36, EQ-5D, patients’ self-reported perceived recovery,
radiographic cervical curvature, and adjacent segment degeneration parameters at baseline
and until two years after surgery. BBraun Medical paid €298.837 to cover the costs
for research nurses.
RESULTS
The NDI declined from 41 to 47 points at baseline to 19 ± 15 in the ACD group, 19 ± 18
in the ACDF group, and 20 ± 22 in the ACDA group after surgery (p=.929). VAS arm and
neck pain declined to half its baseline value and decreased below the critical value
of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. Adjacent
segment degeneration parameters were comparable in all three groups as well. No statistical
differences were demonstrated between the treatment groups.
CONCLUSIONS
The hypothesis that ACDA would lead to superior clinical outcome in comparison to
ACDF or ACD could not be confirmed during a 2-year follow-up time period. Single level
ACD without implanting an intervertebral device may be a reasonable alternative to
ACDF or ACDA.
Keywords
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Article info
Publication history
Published online: December 21, 2018
Accepted:
December 18,
2018
Received in revised form:
December 17,
2018
Received:
June 27,
2018
Footnotes
FDA device/drug status: Not applicable.
Grant: BBraun Medical (F, paid directly to institution).
Author disclosures: CLAV-L: Grant: BBraun Medical (F, paid directly to institution). Speaking/Teaching Arrangements: CSRS (A), CSRS AP (A). Research Support (Investigator Salary, Staff/Materials): Medtronic, Paradigm, Covidien (paid direclty to institution), Dutch National Organization (paid directly to institution). Fellowship Support: Chinese Student Council (student support/sponsorship). TMHJ: Grant: BBraun Medical (F, paid directly to institution). EVZ: Nothing to disclose. CMWG: Grant: BBraun Medical (F, paid directly to institution). LB: Grant: BBraun Medical (F, paid directly to institution). WP: Grant: BBraun Medical (F, paid directly to institution), Hersenstichting Brain Foundation Netherlands (G, paid directly to institution), Center TBI (F, paid directly to institution). MPA: Royalties: EIT (amount not disclosed). Stock Ownership: Galapagos (amount not disclosed), Nuvasive (amount not disclosed). Consulting: Zimmer-Biomet (amount not disclosed, paid directly to institution), EIT (amount not disclosed, paid directly to institution), Silony (amount not disclosed, paid directly to institution), Intrinsics (amount not disclosed, paid directly to institution). Research Suppport: Zimmer-Biomet (amount not disclosed, paid directly to institution) EIT (amount not disclosed, paid directly to institution), Instrinsics (amount not disclosed, paid directly to institution).
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