Laminectomy without or with dorsal Fusion for cervical myeloradiculopathy: a randomised trial
| ISRCTN | ISRCTN72800446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72800446 |
| Secondary identifying numbers | 2007/01 |
- Submission date
- 13/02/2007
- Registration date
- 11/06/2007
- Last edited
- 30/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Ronald Bartels
Scientific
Scientific
Neurosurgical Centre Nijmegen
Radboud University Nijmegen
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 361 3447 |
|---|---|
| r.bartels@nch.umcn.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | LamiFuse |
| Study hypothesis | Patients that are surgically treated for signs and symptoms due to a stenosis of the cervical spinal canal have a better clinical outcome when a dorsal fusion is performed in addition to a laminectomy compared to those that have solely a laminectomy. At the end of the study, the quality of life, complications, and the costs will be evaluated comparing these two treatment groups. |
| Ethics approval(s) | Approval received from the local ethics board (Commissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen) on the 8th May 2007 (ref: CMO nr. 2007/052 and ABR nr: NL166633.091.07). |
| Condition | Cervical myelopathy due to cervical spinal stenosis |
| Intervention | Laminectomy versus laminectomy and fusion. |
| Intervention type | Other |
| Primary outcome measure | Clinical outcome measured by the modified version of the Japanese Orthopedics Association scale (mJOA) score. This will be measured at six weeks, three months and one year after surgery. |
| Secondary outcome measures | 1. Quality of life, measured using the 36-item Short Form health survey (SF-36) 2. Complications 3. Costs These will be measured at six weeks, three months and one year after surgery. |
| Overall study start date | 09/01/2007 |
| Overall study end date | 09/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Patients with a minimal age of 60 years 2. At neurologic examination myelopathic changes must be apparent 3. At Magnetic Resonance Imaging (MRI), concordant stenotic alterations at the cervical level(s) must be present 4. At the plain sitting lateral radiograph a lordotic spine must be shown 5. The shape of the cervical spine is lordotic when the vertebral bodies of C3 to C6 are in front of a line drawn from a point of the posterior inferior part of C2 to a point at the posterior superior part of C7 |
| Participant exclusion criteria | 1. Previous cervical surgery for myelopathic signs and symptoms 2. Solely radiculopathy, or most important complaint 3. Unable to undergo MRI 4. Life expectancy less than two years 5. Other diseases interfering with neurologic symptoms and signs, for example spinal cord glioma, thoracic herniated disc with spinal cord compression, multiple sclerosis etc. 6. Rheumatoid arthritis 7. Trauma to the neck in history 8. Diseases interfering with rehabilitation, for example severe cardiac congestive disease 9. Participation in another study |
| Recruitment start date | 09/01/2007 |
| Recruitment end date | 09/01/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Neurosurgical Centre Nijmegen
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
Radboud University Nijmegen (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurosurgery
R. Postlaan 4
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 361 3477 |
|---|---|
| r.bartels@nch.umcn.nl | |
| Website | http://www.nccn.nl |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Other
Insurances will be paid by the Neurosurgical Centre Nijmegen (The Netherlands). All other costs for the trial will be covered by the Principal Investigator. If financial sponsors are found, these costs will be settled.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/11/2007 | Yes | No |
