The Norwegian Cervical Arthroplasty Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2017-08-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Radiculopathy, Cervical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Artificial Cervical Disc

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

Group Type EXPERIMENTAL

Cervical arthroplasty

Intervention Type PROCEDURE

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

ACDF

Anterior cervical discectomy and fusion (ACDF)

Group Type ACTIVE_COMPARATOR

Anterior cervical discectomy and fusion (ACDF)

Intervention Type PROCEDURE

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

Interventions

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Cervical arthroplasty

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

Intervention Type PROCEDURE

Anterior cervical discectomy and fusion (ACDF)

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

Intervention Type PROCEDURE

Other Intervention Names

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Discover™ Artificial Cervical Disc Cage is made of polyetheretherketone (PEEK)

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No