Total disc replacement versus fusion in cervical radiculopathy
| ISRCTN | ISRCTN44347115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44347115 |
| Protocol serial number | N/A |
| Sponsor | DePuy Spine (Sweden) |
| Funders | DePuy Spine, Inc (Sweden), Johnson & Johnson AB (Sweden) |
- 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
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
Scientific
Stockholm Spine Center
Löwenströmska Sjukhuset
Upplands Väsby
19489
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Total disc replacement versus fusion in cervical radiculopathy: a multicenter randomized controlled trial |
| Study objectives | Null 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) studied | 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 |
| Primary outcome measure(s) |
Neck Disability Index (NDI) at 2 years follow up after intervention |
| Key secondary outcome measure(s) |
1. Visual Analaogue Scale (VAS) neck/arm |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/05/2007 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Sweden
Study participating centre
19489
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
