RecruitingNCT05538416
Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
Sponsor
Jos M. A. Kuijlen
Enrollment
180 participants
Start Date
Sep 19, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- years
- Degenerative or spondylolytic spondylolisthesis
- Neurogenic claudication and/or radicular leg pain
- Low grade (Meyerding grade l and ll)
- Persistent complaints for over 3 months
Exclusion Criteria12
- Previous spine fusion surgery at the same level
- Osteoporosis
- Active infection or prior infection at the surgical site
- Active cancer
- Spondylolisthesis grade lll or greater
- More than one symptomatic level that needs fusion
- Pregnancy
- Contraindication for surgery
- Severe mental or psychiatric disorder
- Substance abuse
- Inadequate knowledge of Dutch language
- Morbid obesity (body mass index \>40)
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Interventions
PROCEDUREPosterior Lumbar Interbody Fusion (PLIF)
Spinal 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.
Locations(1)
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NCT05538416
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