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The Norwegian Cervical Arthroplasty Trial (NORCAT)

Primary Purpose

Radiculopathy, Cervical

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cervical arthroplasty
Anterior cervical discectomy and fusion (ACDF)
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy, Cervical focused on measuring Radiculopathy, cervical, Nerve Root Compression, Disc, intervertebral, Intervertebral Disk Displacement, Spondylosis, Spinal Osteophytosis, Arthroplasty, replacement, Diskectomy, Spinal Fusion

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artificial Cervical Disc

ACDF

Arm Description

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

Anterior cervical discectomy and fusion (ACDF)

Outcomes

Primary Outcome Measures

change in Neck Disability Index (NDI)

Secondary Outcome Measures

Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity
Health economical aspects, measuring hospital costs, patient costs, primary health service costs, and performing cost-utility analyses.
Adjacent level disc disease, measured by use of MRI scans.
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)

Full Information

First Posted
August 13, 2008
Last Updated
January 10, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
Rikshospitalet University Hospital, Haukeland University Hospital, Ullevaal University Hospital, University Hospital of North Norway, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00735176
Brief Title
The Norwegian Cervical Arthroplasty Trial
Acronym
NORCAT
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2008 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Rikshospitalet University Hospital, Haukeland University Hospital, Ullevaal University Hospital, University Hospital of North Norway, St. Olavs Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Cervical
Keywords
Radiculopathy, cervical, Nerve Root Compression, Disc, intervertebral, Intervertebral Disk Displacement, Spondylosis, Spinal Osteophytosis, Arthroplasty, replacement, Diskectomy, Spinal Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Cervical Disc
Arm Type
Experimental
Arm Description
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
Arm Title
ACDF
Arm Type
Active Comparator
Arm Description
Anterior cervical discectomy and fusion (ACDF)
Intervention Type
Procedure
Intervention Name(s)
Cervical arthroplasty
Other Intervention Name(s)
Discover™ Artificial Cervical Disc
Intervention Description
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
Intervention Type
Procedure
Intervention Name(s)
Anterior cervical discectomy and fusion (ACDF)
Other Intervention Name(s)
Cage is made of polyetheretherketone (PEEK)
Intervention Description
Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.
Primary Outcome Measure Information:
Title
change in Neck Disability Index (NDI)
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Adjacent level disc disease, measured by use of MRI scans.
Time Frame
Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein P Nygaard, Professor MD
Organizational Affiliation
Department of Neurosurgery, St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7004
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27061727
Citation
Sundseth J, Jacobsen EA, Kolstad F, Sletteberg RO, Nygaard OP, Johnsen LG, Pripp AH, Andresen H, Fredriksli OA, Myrseth E, Zwart JA. Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT). Eur Spine J. 2016 Jul;25(7):2271-8. doi: 10.1007/s00586-016-4549-6. Epub 2016 Apr 9.
Results Reference
background
PubMed Identifier
28012081
Citation
Sundseth J, Fredriksli OA, Kolstad F, Johnsen LG, Pripp AH, Andresen H, Myrseth E, Muller K, Nygaard OP, Zwart JA; NORCAT study group. The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study. Eur Spine J. 2017 Apr;26(4):1225-1235. doi: 10.1007/s00586-016-4922-5. Epub 2016 Dec 23.
Results Reference
result
PubMed Identifier
34351401
Citation
Johansen TO, Sundseth J, Fredriksli OA, Andresen H, Zwart JA, Kolstad F, Pripp AH, Gulati S, Nygaard OP. Effect of Arthroplasty vs Fusion for Patients With Cervical Radiculopathy: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2119606. doi: 10.1001/jamanetworkopen.2021.19606.
Results Reference
derived

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The Norwegian Cervical Arthroplasty Trial

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