About this trial
A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-75 years
Degenerative or spondylolytic spondylolisthesis
Neurogenic claudication and/or radicular leg pain
Low grade (Meyerding grade l and ll)
Disqualifiers
Previous spine fusion surgery at the same level
Osteoporosis
Active infection or prior infection at the surgical site
Active cancer
Trial population
A total of 180 participants, 60 prospective CBT-PLIF participants, 60 retrospective open-PLIF and 60 retrospective MI-PLIF participants. Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to a low grade (Meyerding grade l and ll) degenerative or spondylolytic spondylolisthesis with persistent complaints for over 3 months will be included in the study. Patients are operated in either the University Medical Centre Groningen (UMCG) or in the Haaglanden Medical Centre (HMC).
Trial design
Cohort
Other
Treatments tested in this trial
Posterior Lumbar Interbody Fusion (PLIF)
Procedure/SurgerySpinal fusion in the lumbar spine by inserting a cage directly into the disc space. This is an observational study in which the standard procedure/care is followed.
Treatment groups
Trial outcomes
Primary outcomes
VAS low back pain
VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Secondary outcomes
VAS low back pain
VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
VAS leg pain
VAS for leg pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Oswestry Disability Index
Used to quantify the degree of functional impairment in patients with low back pain. Ranging from 0 (no disability) to 100 (bed bound)
Quality of Life (QoL)
Measured by the EQ-5D-5L
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jos M. A. Kuijlen
Lead sponsor
University Medical Center Groningen
Sponsor institution