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.
ID
Bron
Verkorte titel
Aandoening
minimally invasive surgery, spondylolisthesis, lumbar fusion, spine surgery.
minimaal invasieve chirurgie, spondylolisthesis, lumbale fusie, wervelkolom chirurgie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Score on the Visual Analoge Scale (VAS) for low back pain (ranging from 0 - 100 mm) in the first 6 weeks after surgery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative.
Onderzoeksproduct en/of interventie
Minimally invasive lumbar pedicle screw fixation with interbody fusion, versus open conventional pedicle screw fixation with interbody fusion.
Publiek
Lijnbaan 32
M.P. Arts
Den Haag 2512 VA
The Netherlands
+31-70-3302054
m.arts@mchaaglanden.nl
Wetenschappelijk
Lijnbaan 32
M.P. Arts
Den Haag 2512 VA
The Netherlands
+31-70-3302054
m.arts@mchaaglanden.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL4335 |
NTR-old | NTR4532 |
Ander register | METC : 14-046 |