Overview

This trial is active, not recruiting.

Condition radiculopathy, cervical
Treatments cervical arthroplasty, anterior cervical discectomy and fusion (acdf)
Sponsor Norwegian University of Science and Technology
Collaborator Rikshospitalet University Hospital
Start date September 2008
End date July 2018
Trial size 146 participants
Trial identifier NCT00735176, 18809/2/AMS, 4.2008.211 (REK)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
cervical arthroplasty Discover™ Artificial Cervical Disc
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
(Active Comparator)
Anterior cervical discectomy and fusion (ACDF)
anterior cervical discectomy and fusion (acdf) Cage is made of polyetheretherketone (PEEK)
Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
Adjacent level disc disease, measured by use of MRI scans.
time frame: 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

Eligibility Criteria

Male or female participants from 25 years up to 60 years old.

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

Additional Information

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.
Principal investigator Andreas Bliksås, Cand.Med.
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.