Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
NCT ID: NCT05538416
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2022-09-19
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Open PLIF
Patients undergoing conventional open posterior lumbar interbody fusion (PLIF) surgery. A long midline skin incision (10-15 cm) is made, after which the paravertebral muscles are detached from the midline and retracted laterally in order to expose the facet joints and pedicle entry point. After the pedicle screws are positioned, the disc will be removed bilaterally and packed with autogenous bone chips, followed by bilateral placement of polyetheretherketone (PEEK) PLIF cages.
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.
CBT-PLIF
Patient undergoing minimal access PLIF surgery with cortical bone trajectory (CBT-PLIF). The CBT-PLIF uses more medialized entry points, closer to the spinal process. Due to the medial approach of this technique, a smaller incision is needed and the need to retract muscles laterally is minimalized.
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.
MI-PLIF
Patients undergoing minimal invasive PLIF surgery. A small midline incision (3-5 cm) will be made to perform mini-open decompression and placement of bilateral PEEK PLIF cages. In addition, two small paramedian incisions will be made on both sides for percutaneous pedicle screw fixation.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Jos M. A. Kuijlen
OTHER
Responsible Party
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Jos M. A. Kuijlen
Dr. MD, PhD
Principal Investigators
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Jos M.A. Kuijlen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen
Locations
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UMCG
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UMCG202200129
Identifier Type: -
Identifier Source: org_study_id
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