NL-OMON53233
Not yet recruiting
Phase 4
Minimally Invasive versus Open Lumbar Interbody Fusion Trial (MIOLIFT): a randomized controlled trial for surgical treatment of lumbar spondylolisthesis and foraminal stenosis - MIOLIFT
Zuyderland Medisch Centrum0 sites198 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zuyderland Medisch Centrum
- Enrollment
- 198
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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