Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF)

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00735176
First received: August 13, 2008
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Radiculopathy, Cervical
Procedure: Cervical arthroplasty
Procedure: Anterior cervical discectomy and fusion (ACDF)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Clinical effect, measured by use of the Neck Disability Index (NDI) [ Time Frame: Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]

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 [ Time Frame: Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Adjacent level disc disease, measured by use of MRI scans. [ Time Frame: Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 146
Study Start Date: September 2008
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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: B
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)

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).

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735176

Locations
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
Study Chair: Øystein P Nygaard, Professor MD Department of Neurosurgery, St. Olavs Hospital. The National Centre for Spinal Diseases.
Principal Investigator: Andreas Bliksås, Cand.Med. Department of Neurosurgery, St. Olavs Hospital
Principal Investigator: Jarle Sundseth, Cand.Med. Department of Neurosurgery, Rikshospitalet University Hospital
  More Information

No publications provided

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
Study First Received: August 13, 2008
Last Updated: April 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

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:
Radiculopathy
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014