IFT onderzoek
Recruiting
- Conditions
- umbar fusion, degenerative disease lumbar spine, lumbar instability, spondylolisthesis, cost effectiveness, quality of life.Lumbale fusie, degeneratieve lumbale wervelkolom, lumbale instabiliteit, spondylolisthesis, kosten effectiviteit, kwaliteit van leven.
- Registration Number
- NL-OMON24335
- Lead Sponsor
- Principal investigator: dr. Henk van SantbrinkAcademisch fonds/Guy Peeters fonds - Academisch ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
Indication for TLIF (transforaminal lumbar interbody fusion) of PLIF (posterior lumbar interbody fusion) surgery.
- Clinical mono uni-or bilateral lumbar radiculopathy or intermittent neurogenic claudication caused by a single level isthmic, degenerative or iatrogenic spondylolisthesis gr I, II or III according to Meyerding classification at level L3L4, L4L5 or L5S1.
Exclusion Criteria
-Previous radiotherapy at the intended surgical level.
-(Progressive) motor failure and/or anal sphincter disorders which urges instant intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in disability measured by the change in Oswestry Disability Index (ODI) and changes in quality-adjusted life years (QALYs) measured with EQ-5D-DL.
- Secondary Outcome Measures
Name Time Method Short Form (36) Health Survey, VAS back pain and leg pain, Hospital Anxiety Depression Scale (HADS), complications, productivity losses costs (iPCQ), medical costs (iMCQ), valuation of informal care (iVICQ)