The Norwegian Cervical Arthroplasty Trial (NORCAT)

January 10, 2019 updated by: Norwegian University of Science and Technology

Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anterior discectomy and fusion (ACDF) is in Norway currently the most common operative method against cervical radiculopathy, caused by disc herniation and/or spondylosis. In the last decade cervical arthroplasty has emerged as a new alternative operative method. Arthroplasty is claimed to preserve the natural motion of the spine, thereby preventing adjacent level disc disease and providing better clinical results. However, this hypothesis has not yet been adequately proven. In our study, we will prove if there is any real difference in terms of clinical effect between cervical arthroplasty and ACDF.We will also compare the overall costs of the two methods, including cost-utility analyses. Moreover, we will study the development of adjacent level disease by use of MRI scans, and analyze cervical spine motion and disc height by use of Distortion Compensated Roentgen Analysis (DCRA).

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7004
        • St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 25 - 60 years
  • Clinical C6 or C7 root radiculopathy with corresponding radiologic findings with or without neurological symptoms
  • Mechanical provoked pain which aggravate with physical activity or positive Spurling test
  • Radiological nerve root compression on the basis of disc herniation or spondylosis
  • NDI =/> 30 percent
  • The patient has not responded to non-operative treatment and shown no sign of improvement during the last 6 weeks

Exclusion Criteria:

  • Significant spondylosis involving more than one level
  • Intramedullary changes on MRI
  • Ankylosis at adjacent level
  • Clinical suspicion of myelopathy
  • Chronic generalised pain syndrome
  • Infection
  • Active cancer
  • Rheumatoid arthritis involving the cervical spine
  • Previous trauma involving the cervical spine
  • Pregnancy
  • Allergy against contents in cage/artificial disc
  • Previous neck surgery
  • Psychological or somatic illness that causes the patient not to be suitable for the study
  • The patient does not understand Norwegian orally or in writing.
  • Abuse of medication/narcotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artificial Cervical Disc
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
Procedure: Cervical arthroplasty
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
Other Names:
  • Discover™ Artificial Cervical Disc
Active Comparator: ACDF
Anterior cervical discectomy and fusion (ACDF)
Procedure: Anterior cervical discectomy and fusion (ACDF)
Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.
Other Names:
  • Cage is made of polyetheretherketone (PEEK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in Neck Disability Index (NDI)
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity
Time Frame: Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
Health economical aspects, measuring hospital costs, patient costs, primary health service costs, and performing cost-utility analyses.
Time Frame: Postoperatively: 3 months, 6 months, 1 year, 2 years
Postoperatively: 3 months, 6 months, 1 year, 2 years
Adjacent level disc disease, measured by use of MRI scans.
Time Frame: Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years
Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years
Preservation of cervical translational and rotational segmental motion, disc height and dorsoventral displacement, by use of functional X-rays with Distortion Compensated Roentgen Analysis (DCRA)
Time Frame: Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years
Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Ullevaal University Hospital
University Hospital of North Norway
Haukeland University Hospital
St. Olavs Hospital
Rikshospitalet University Hospital

Investigators

  • Study Chair: Øystein P Nygaard, Professor MD, Department of Neurosurgery, St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.2008.211 (REK)
  • 18809/2/AMS (Other Identifier: NSD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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