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Completed

NCT Number: NCT00735176

The Norwegian Cervical Arthroplasty Trial

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical arthroplasty

Procedure

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

Other names: Discover™ Artificial Cervical Disc

Anterior cervical discectomy and fusion (ACDF)

Procedure

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

Other names: Cage is made of polyetheretherketone (PEEK)

Primary outcomes

  1. change in Neck Disability Index (NDI)

    Time frame: up to 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NORCAT

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2008
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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