|- candidate number||17549|
|- NTR Number||NTR4532|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-apr-2014|
|- Secondary IDs||14-046 METC|
|- Public Title||Minimally invasive lumbar fusion versus conventional open lumbar fusion in the treatment of patients with spondylolisthesis.|
|- Scientific Title||Minimally Invasive Surgery versus Open Surgery (MISOS) in the treatment of spondylolisthesis; a randomised controlled trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Minimally invasive surgical procedures, Spondylolisthesis, Lumbal spinal surgery |
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-sep-2019|
|- Target number of participants||184|
|- Interventions||Minimally invasive lumbar pedicle screw fixation with interbody fusion, versus open conventional pedicle screw fixation with interbody fusion.|
|- 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).|
|- Timepoints||baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD PhD M.P. Arts|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.P. Arts|
|- Sponsor/Initiator ||Medical Center Haaglanden|
(Source(s) of Monetary or Material Support)
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||22-apr-2014 - 13-mei-2014|