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

Plain English Summary

Lay summary under review 2

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 multi center 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 March 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

The two different treatments consists of:
1. Fusion with iliac crest bone graft and platefixation
2. Discover Artificial Disc (DePuy Spine). Both groups followed up with baseline data, 3 months, 1 year, 2 years and 5 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Neck Disability Index (NDI), 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