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The Norwegian Cervical Arthroplasty Trial

NCT00735176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2019-01-11

No results posted yet for this study

Summary

The study will compare cervical arthroplasty with cervical discectomy and fusion, in the treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between the two methods, when comparing primary and secondary outcome variables.

Conditions

  • Radiculopathy, Cervical

Interventions

PROCEDURE

Cervical arthroplasty

Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc

PROCEDURE

Anterior cervical discectomy and fusion (ACDF)

Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.

Sponsors & Collaborators

  • Rikshospitalet University Hospital

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Ullevaal University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Øystein P Nygaard, Professor MD · Department of Neurosurgery, St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735176 on ClinicalTrials.gov