Minimally Invasive versus Open Lumbar Interbody Fusion Trial (MIOLIFT): a randomized controlled trial for surgical treatment of lumbar spondylolisthesis and foraminal stenosis

Phase 4

• Conditions: spinal canal stenosis; nerve pain; 10005944

• Registration Number: NL-OMON53233
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 198

Inclusion Criteria

- Indication for MITLIF (minimal invasive transforaminal lumbar interbody
fusion) or OTLIF (open transforaminal lumbar interbody fusion) surgery.
- Clinical mono uni- or bilateral lumbar radiculopathy or intermittent
neurogenic claudication caused by a single level degenerative foraminal
stenosis or isthmic, iatrogenic, or degenerative spondylolisthesis gr I or II
according to Meyerding classification at level L3L4, L4L5 or L5S1.
- Age over 18 years.
- Single level degenerative foraminal stenosis or isthmic, iatrogenic, or
degenerative spondylolisthesis causing central stenosis on MRI (or CT), of
which the anatomical level is corresponding to the clinical syndrome.
- Psychosocially, mentally, and physically able to fully comply with this study
protocol.
- Informed consent prior to this study.

Exclusion Criteria

- Previous radiotherapy at the intended surgical level.
- (Progressive) motor failure and/or anal sphincter disorders which urges
instant intervention.
- Active spinal infection.
- Immature bone (on-going growth).
- Active malignancy.
- Pregnancy.
- Symptomatic osteoporosis (Current or previous use of bisphosphonates).
- Contra-indications for anaesthesia or surgery.
- Inadequate command of the Dutch language.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in quality-adjusted life years (QALY) measured with EQ-5D-5L.</p><br>