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Minimally invasive lumbar fusion versus conventional open lumbar fusion in the treatment of patients with spondylolisthesis.

Minimally Invasive Surgery versus Open Surgery (MISOS) in the treatment of spondylolisthesis; a randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28885
Enrollment
184
Registered
2014-04-22
Start date
2014-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

minimally invasive surgery, spondylolisthesis, lumbar fusion, spine surgery. minimaal invasieve chirurgie, spondylolisthesis, lumbale fusie, wervelkolom chirurgie

Interventions

Minimally invasive lumbar pedicle screw fixation with interbody fusion, versus open conventional pedicle screw fixation with interbody fusion.

Sponsors

Medical Center Haaglanden
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Score on the Visual Analoge Scale (VAS) for low back pain (ranging from 0 - 100 mm) in the first 6 weeks after surgery.

Secondary

MeasureTime frame
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).

Contacts

Public ContactM.P. Arts

Dept of Neurosurgery, Medical Center Haaglanden Lijnbaan 32

m.arts@mchaaglanden.nl+31-70-3302054

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)