umbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis.

Recruiting

Conditions: displacement of a lumbar vertebra
Spondylolisthesis
10041543
10009720

Registration Number: NL-OMON50249

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

1. Indication for TLIF (transforaminal lumbar interbody fusion) of PLIF
(posterior lumbar interbody fusion) surgery.
2. 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.
3. Age over 18 years.
4. Single level spondylolisthesis with central or foraminal stenosis on MRI (or
CT), of which the anatomical level is corresponding to the clinical syndrome.
5. Psychosocially, mentally, and physically able to fully comply with this
study protocol.
6. Informed consent prior to this study., Inclusioncriteria of informal
caregivers of patients:
1. The patient where the ICG offers his care, has to participate in the
LIFT-study.
2. Age over 18 years
3. Psychosocially, mentally, and physically able to fully comply with this
study protocol.
4. Informed consent prior to this study.

Exclusion Criteria

1. Previous radiotherapy at the intended surgical level.
2. (Progressive) motor failure and/or anal sphincter disorders which urges
instant intervention.
3. Active spinal infection.
4. Immature bone (on-going growth).
5. Active malignancy.
6. Pregnancy.
7. Symptomatic osteoporosis (based on DEXA-scan).
8. Contra-indications for anaesthesia or surgery.
9. Inadequate command of the Dutch language., Exclusioncriteria of informal
caregivers of patients:
1. Inadequate command of the Dutch language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine change in Oswestry Disability Index. This can be obtained by<br /><br>completing the ODI-questionnaire pre- and postoperatively. This functional<br /><br>score is a tool for measuring patients permanent functional disability,<br /><br>specially designed for patients with low back related disabilities.<br /><br>To determine change in quality of life adjusted years (QALY) with EQ-5D-5L,<br /><br>measured pre- and postoperatively. The EQ-5D-5L is a questionnaire to<br /><br>determine the quality-adjusted life years associated with a health state.</p><br>

Secondary Outcome Measures