LIFT onderzoek

A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24335

Enrollment

160

Registered

2016-03-30

Start date

2016-09-01

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

Lumbar 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.

Interventions

TLIF (transforaminal lumbar interbody fusion) or PLIF (posterior lumbar interbody fusion) (1:1 randomization).

Eligibility

Inclusion criteria

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. - Age over 18 years. - Single level spondylolisthesis with central or foraminal 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

Exclusion criteria: - Previous radiotherapy at the intended surgical level. - (Progressive) motor failure and/or anal sphincter disorders which urges instant intervention. - Active infection. - Immature bone (ongoing growth). - Active malignancy. - Pregnancy. - Symptomatic osteoporosis. - Contra-indications for anaesthesia or surgery. - Inadequate command of the Dutch language.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Contacts

Public ContactI.J.M.H. Caelers

Zuyderland medical center Heerlen, Neurosurgery

inge.caelers@mumc.nl+31 6 52593545

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)