Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posterior Lumbar Interbody Fusion (PLIF).
- Who it may be relevant to
- Registry conditions: Degenerative Spondylolisthesis, Spondylolytic Spondylolisthesis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of 180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60 retrospective open PLIF patients and 60 retrospective MI-PLIF patients.
The new data will be collected prospectively by means of questionnaires. No biomaterial will be collected. The included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery.
Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months.
Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass index \>40).
Main research question: Does the CBT-PLIF provide less low back pain in the short term than the traditional open PLIF and the MI-PLIF?
Primary outcome measure
* Low back pain measured with the Visual Analogue Scale (VAS) 2 weeks after surgery Secondary Outcomes * Low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery * Leg pain * Oswestry Disability Index * Quality of life (EQ-5D-5L) * Observed patient recovery * Other parameters such as complications, surgical parameters (intraoperative blood loss, duration of surgery), length of stay in hospital and return to work
Interventions
- Procedure Posterior 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.
Primary outcome measures
- VAS low back pain [Time frame: 2 weeks postoperative]
Secondary outcome measures (5)
- VAS low back pain [Time frame: During hospital stay, measured each day and 6 weeks postoperative]
- VAS leg pain [Time frame: During hospital stay, measured each day, 2 and 6 weeks postoperative]
- Oswestry Disability Index [Time frame: 2 and 6 weeks postoperative]
- Quality of Life (QoL) [Time frame: 2 and 6 weeks postoperative]
- Perceived recovery of the patient [Time frame: 2 and 6 weeks postoperative]
Eligibility criteria
Inclusion criteria
- 18-75 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- UMCG — Groningen
Identifiers
NCT: NCT05538416 · UMCG202200129