The NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study.
BACKGROUND
Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation.


METHODS
Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years.


CONCLUSIONS
Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prosthesis is necessary and cost-effective will be determined by this trial.


BACKGROUND
Netherlands Trial Register NTR1289.
Arts
Mark P
MP
Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands. m.arts@mchaaglanden.nl
Brand
Ronald
R
van den Akker
Elske
E
Koes
Bart W
BW
Peul
Wilco C
WC
D000293:Adolescent; D000328:Adult; D000368:Aged; D001178:Arthroplasty / Q000191:economics* / Q000379:methods; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D003362:Cost-Benefit Analysis; D017586:Diskectomy / Q000191:economics* / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016268:Internal Fixators / Q000191:economics / Q000592:standards; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000191:economics / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D019919:Prosthesis Implantation / Q000191:economics / Q000379:methods; D011843:Radiculopathy / Q000000981:diagnostic imaging / Q000601:surgery; D011859:Radiography; D013123:Spinal Fusion / Q000191:economics* / Q000379:methods; D055009:Spondylosis / Q000191:economics / Q000601:surgery*; D055815:Young Adult