Condition category
Musculoskeletal Diseases
Date applied
17/02/2012
Date assigned
19/03/2012
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Martin Skeppholm

ORCID ID

Contact details

Stockholm Spine Center
Löwenströmska Sjukhuset
Upplands Väsby
19489
Sweden

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/04/2017: Plain English summary added.