Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Norwegian Cervical Arthroplasty Trial (NORCAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735176
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Haukeland University Hospital
Ullevaal University Hospital
University Hospital of North Norway
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Radiculopathy, Cervical Procedure: Cervical arthroplasty Procedure: Anterior cervical discectomy and fusion (ACDF) Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.
Actual Study Start Date : September 2008
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

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 Name: 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 Name: Cage is made of polyetheretherketone (PEEK)




Primary Outcome Measures :
  1. change in Neck Disability Index (NDI) [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Adjacent level disc disease, measured by use of MRI scans. [ Time Frame: Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years ]
  4. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735176


Locations
Layout table for location information
Norway
St. Olavs Hospital
Trondheim, Norway, 7004
Sponsors and Collaborators
Norwegian University of Science and Technology
Rikshospitalet University Hospital
Haukeland University Hospital
Ullevaal University Hospital
University Hospital of North Norway
St. Olavs Hospital
Investigators
Layout table for investigator information
Study Chair: Øystein P Nygaard, Professor MD Department of Neurosurgery, St. Olavs Hospital

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00735176     History of Changes
Other Study ID Numbers: 4.2008.211 (REK)
18809/2/AMS ( Other Identifier: NSD )
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Keywords provided by Norwegian University of Science and Technology:
Radiculopathy, cervical
Nerve Root Compression
Disc, intervertebral
Intervertebral Disk Displacement
Spondylosis
Spinal Osteophytosis
Arthroplasty, replacement
Diskectomy
Spinal Fusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases