A prospective, randomized double-blind multicenter trial among patients with cervical radiculopathy due to single-level disc herniation was conducted. Patients were randomly assigned into three groups: anterior cervical discectomy with arthroplasty (ACDA; activC, Aesculap AG, Tuttlingen, Germany), anterior cervical discectomy with fusion (ACDF; Cage standalone) and anterior cervical discectomy without fusion (ACD). The design and study protocol were published previously.13 (link) The protocol was approved by medical ethics committees, including an approval for randomization after anesthetic induction. All patients gave informed consent. The 2-year follow-up data revealed no differences in clinical outcomes.14 (link)
Protocol detail
Cervical Radiculopathy Treatment Comparison
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Anesthetic
Arthroplasty
Cervical
Cervical radiculopathy
Disc herniation
Discectomy
Ethics committees
Patients
Corresponding Organization : Leiden University Medical Center
Other organizations : Kliniek ViaSana, Medisch Centrum Haaglanden, Radboud University Nijmegen, Radboud University Medical Center
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Variable analysis
independent variables
- Anterior cervical discectomy with arthroplasty (ACDA; activC, Aesculap AG, Tuttlingen, Germany)
- Anterior cervical discectomy with fusion (ACDF; Cage standalone)
- Anterior cervical discectomy without fusion (ACD)
- Clinical outcomes
- Patients with cervical radiculopathy due to single-level disc herniation
- Positive control: Not mentioned
- Negative control: Not mentioned
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