What is the cost-effectiveness of minimal invasive posterior lumbar interbody fusion in spinal stenosis patients, compared to the standard open fusion?
ID
Source
Brief title
Condition
- Joint disorders
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is the time spent in recovered state during the first
year on the Oswestry Disability Index (ODI).
Secondary outcome
Secondary outcome parameters are Quality of life (EuroQoL, transformed QoL VAS,
SF36), cost, VAS leg and VAS back pain, ZCQ, Likert perceived recovery, Likert
satisfaction, complications, perioperative morbidity, fusion.
Background summary
Minimal invasive surgery is expected to increase the length of recovery after
lumbar spine spondylodesis and thereby lowering the cost from societal
perspective (faster return to work, less medical consumption, shorter hospital
stay, fewer infections).
Study objective
What is the cost-effectiveness of minimal invasive posterior lumbar interbody
fusion in spinal stenosis patients, compared to the standard open fusion?
Study design
Multicenter, randomized controlled trial.
Intervention
Intervention: One level, minimal invasive surgery for decompression and
interbody fusion. Minimal invasive access for decompression is accomplished by
a muscle splitting approach using tubular retractors. Interbody fusion is
accomplished through the same muscle corridors. Screw and rod fixation will be
added through 4 additional small incisions.
Control intervention: Standard open decompression and interbody fusion with
relatively large midline incision and muscle detachment from the midline bone.
Screw and rod fixation through the same open access.
Study burden and risks
This study is judged as having negligible (*verwaarloosbaar*) risks due to
participation. There is a concern for nerve root damage from inserting the
screws, due to the reduced view of the operative field. But an increased risk
has not been observed in current effectiveness trials. The burden for the
patient of participation are extra site visits, one blood sample, and the
completion of questionnaires and diaries.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
Inclusion criteria
- Neurogenic claudication or radicular leg pain.
- Complaints are due to MRI confirmed existence of lytic or degenerative spondylolisthesis of maximal 50% or Meyerding Grade II, or spinal stenosis accompanied by severe facet degeneration (grade 2 or 3 according to Weishaupt (Skeletal Radiol 1999; 28 (4):215-9), at one or two levels
- Single or double level fusion indicated.
- Insufficient response to conservative therapy (physical therapy, analgesic medications, or trans-foraminal corticosteroid injections) for at least 6 months.
- Age is between and including 18-70 years.
- Be able to understand the Dutch language and comprehend the questionnaires and patient information.
- Patients signed informed consent.
Exclusion criteria
- Iatrogenic Spondylolisthesis or more than 50% or more than Meyerding Grade II.
- Inflammatory arthritis, Osteoporosis or other metabolic bone disease to a degree that it would influence fusion.
- Contraindication for surgery.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46777.058.13 |