Condition category
Musculoskeletal Diseases
Date applied
13/02/2007
Date assigned
11/06/2007
Last edited
30/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nccn.nl

Contact information

Type

Scientific

Primary contact

Dr Ronald Bartels

ORCID ID

Contact details

Neurosurgical Centre Nijmegen
Radboud University Nijmegen
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 3447
r.bartels@nch.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2007/01

Study information

Scientific title

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

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cervical myelopathy due to cervical spinal stenosis

Intervention

Laminectomy versus laminectomy and fusion.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

09/01/2007

Overall trial end date

09/01/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

60

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

Trial participating centre

Neurosurgical Centre Nijmegen
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

Radboud University Nijmegen (The Netherlands)

Sponsor details

Department of Neurosurgery
R. Postlaan 4
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 3477
r.bartels@nch.umcn.nl

Sponsor type

Hospital/treatment centre

Website

http://www.nccn.nl

Funders

Funder type

Other

Funder name

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.

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

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17996094

Publication citations

  1. Protocol

    Bartels RH, Verbeek AL, Grotenhuis JA, Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy., BMC Musculoskelet Disord, 2007, 8, 111, doi: 10.1186/1471-2474-8-111.

Additional files

Editorial Notes