No registrations found.
ID
Source
Brief title
Health condition
minimally invasive surgery, spondylolisthesis, lumbar fusion, spine surgery.
minimaal invasieve chirurgie, spondylolisthesis, lumbale fusie, wervelkolom chirurgie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Score on the Visual Analoge Scale (VAS) for low back pain (ranging from 0 - 100 mm) in the first 6 weeks after surgery.
Secondary outcome
Oswestry Disability Index (ODI), self perceived recovery according to the patient (Likert), VAS leg pain, quality of life (EQ-5D), re-surgery, complications, and fusion (evaluated on CT).
Background summary
Spondylolisthesis is a relatively frequent pathology of the spine, in which patients usually present with radicular leg pain, with or without low back pain. Whenever the complaints are persistent and invalidating, patients will be offered surgery. The most common procedure is the conventional instrumented surgery with bilateral muscle dissection, decompression of the nerve roots, and correction of the spondylolsthesis with pedicle screw fixation and intercorporal fusion with cages. The last decade, minimally invasive surgery is popularized whereby percutaneous pedicle screws are placed and the nerve roots are decompressed through a small median incision. The rationale of minimally invasive surgery is less muscle damage, reduced postoperative low back pain, and faster recovery. However, until now no randomized controlled trial has been performed on patients with spondylolisthesis, in which minimally invasive fusion is compared with conventional open surgery.
Study objective
Patients treated with MIS will document lower back pain scores on VAS at the short-term follow-up (first 6 weeks after surgery) as compared to open surgery.
Study design
baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative.
Intervention
Minimally invasive lumbar pedicle screw fixation with interbody fusion, versus open conventional pedicle screw fixation with interbody fusion.
Lijnbaan 32
M.P. Arts
Den Haag 2512 VA
The Netherlands
+31-70-3302054
m.arts@mchaaglanden.nl
Lijnbaan 32
M.P. Arts
Den Haag 2512 VA
The Netherlands
+31-70-3302054
m.arts@mchaaglanden.nl
Inclusion criteria
• Age between 18 and 75 years.
• Neurogenic claudication or radicular leg pain with or without low back pain.
• Degenerative or spondylolytic spondylolisthesis with spinal stenosis.
• Persistent complaints for at least 3 months, regardless conservative treatments.
• Be able to understand the Dutch language and comprehend the questionnaires and patient information.
• Written informed consent given.
Exclusion criteria
• Previous spine surgery at the same level.
• Inflammatory arthritis, osteoporosis or other metabolic bone disease that would influence fusion.
• Contraindication for surgery.
• Severe mental or psychiatric disorder.
• Inadequate knowledge of Dutch language.
• Planned (e)migration abroad in the year after inclusion.
Design
Recruitment
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 |
---|---|
NTR-new | NL4335 |
NTR-old | NTR4532 |
Other | METC : 14-046 |