Plain English Summary
Background and study aims
Cervical radiculopathy is where a slipped disc or other bone pinches or irritates a nerve in the cervical spine (neck), resulting in pain. For patients with severe pain that lasts for more than 3 months, surgery can be effective and reduce symptoms. The standard procedure is to decompress the nerve by removing bone or disc material, and fuse the disc joint together. This is an accepted method with good results. Fusion may put more stress on the adjacent discs and may lead to increased degeneration (damage). Artificial discs have been developed as an alternative to fusion and may reduce degeneration and future problems at adjacent discs. The aim of this study is to compare the results of cervical fusion to disc replacement with an artificial disc implant.
Who can participate?
Patients between 18-60 years of age with cervical radiculopathy who have had symptoms for at least 3 months
What does the study involve?
Patients are randomly allocated to undergo decompression with either fusion or disc replacement. All participants are followed up to assess their symptoms after 3 months and 1, 2 and 5 years.
What are the possible benefits and risks of participating?
The use of artificial discs could prevent changes in adjacent discs and therefore lead to a better long term result. As disc replacement is a quite new method there are some potential risks, such as loosening or dislocation of the implant which might lead to further surgery.
Where is the study run from?
1. Stockholm Spine Center (Sweden)
2. Ryhov Hospital (Sweden)
3. Uppsala University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
May 2007 to May 2012
Who is funding the study?
1. DePuy Spine, Inc. (Sweden)
2. Johnson & Johnson AB (Sweden)
Who is the main contact?
Dr Martin Skeppholm
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Total disc replacement versus fusion in cervical radiculopathy: a multicenter randomized controlled trial
Acronym
Study hypothesis
Null hypothesis:
Disc replacement does not give a better outcome than fusion when cervical radiculopathy is treated with surgery.
Ethics approval
Regional Ethics Committee, Stockholm, 31/03/2007, ref: 2006/1266-31/3
Study design
Multicenter randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cervical radiculopathy
Intervention
1. Decompression and fusion of 1-2 cervical levels. Fusion is done with bone graft from iliac crest and anterior plate stabilisation
2. Decompression and disc replacement with Discover disc prosthesis (DePuy Spine)
Both groups are followed up at 3 months, 1 year, 2 years and 5 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Neck Disability Index (NDI) at 2 years follow up after intervention
Secondary outcome measures
1. Visual Analaogue Scale (VAS) neck/arm
2. EQ-5D
3. Dysphagia Short Questionnaire (DSQ)
4. Radiographic evaluation
5. Sick leave
6. Consumption of analgetics
Overall trial start date
20/05/2007
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least 3 months of radiculopathy
2. Associated findings on Magnetic resonance imaging (MRI) at 1-2 levels in cervical spine
3. 18-60 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Previous cervical surgery
2. Drug abuse or other obvious reason for bad compliance
3. History of Whiplash associated disorder (WAD) or severe cervical trauma
4. Rheumatoid arthritis, known malignancy, active infection or other systemic disease
5. Pregnancy
6. Cervical malformations
Recruitment start date
20/05/2007
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Sweden
Trial participating centre
Stockholm Spine Center
Upplands Väsby
19489
Sweden
Sponsor information
Organisation
DePuy Spine (Sweden)
Sponsor details
c/o Johnson & Johnson AB
Staffans väg 2
Sollentuna
SE-191 84
Sweden
Sponsor type
Industry
Website
http://www.jjnordic.com/sv-se/Franchise/DePuySpine/Sidor/default.aspx
Funders
Funder type
Industry
Funder name
DePuy Spine, Inc (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johnson & Johnson AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list