Total disc replacement versus fusion in cervical radiculopathy

ISRCTN ISRCTN44347115
DOI https://doi.org/10.1186/ISRCTN44347115
Secondary identifying numbers N/A
Submission date
17/02/2012
Registration date
19/03/2012
Last edited
20/12/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Martin Skeppholm
Scientific

Stockholm Spine Center
Löwenströmska Sjukhuset
Upplands Väsby
19489
Sweden

Study information

Study designMulticenter randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTotal disc replacement versus fusion in cervical radiculopathy: a multicenter randomized controlled trial
Study objectivesNull hypothesis:
Disc replacement does not give a better outcome than fusion when cervical radiculopathy is treated with surgery.
Ethics approval(s)Regional Ethics Committee, Stockholm, 31/03/2007, ref: 2006/1266-31/3
Health condition(s) or problem(s) studiedCervical radiculopathy
Intervention1. 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 typeOther
Primary outcome measureNeck Disability Index (NDI) at 2 years follow up after intervention
Secondary outcome measures1. 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 study start date20/05/2007
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/05/2007
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • Sweden

Study participating centre

Stockholm Spine Center
Upplands Väsby
19489
Sweden

Sponsor information

DePuy Spine (Sweden)
Industry

c/o Johnson & Johnson AB
Staffans väg 2
Sollentuna
SE-191 84
Sweden

Website http://www.jjnordic.com/sv-se/Franchise/DePuySpine/Sidor/default.aspx

Funders

Funder type

Industry

DePuy Spine, Inc (Sweden)

No information available

Johnson & Johnson AB (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/01/2019 16/01/2019 Yes No
Results article follow up results 01/01/2021 22/01/2021 Yes No
Results article 10-year results 17/12/2021 20/12/2021 Yes No

Editorial Notes

20/12/2021: Publication reference added.
22/01/2021: Publication reference added.
16/01/2019: Publication reference added.
20/04/2017: Plain English summary added.