NCT05538416 Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
| NCT ID | NCT05538416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jos M. A. Kuijlen |
| Condition | Degenerative Spondylolisthesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-09-19 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2022-09-19 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Jos M.A. Kuijlen, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen
Frequently Asked Questions
Who can join the NCT05538416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Degenerative Spondylolisthesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05538416 currently recruiting?
Yes, NCT05538416 is actively recruiting participants. Contact the research team at d.h.steenks@umcg.nl for enrollment information.
Where is the NCT05538416 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT05538416 clinical trial?
NCT05538416 is sponsored by Jos M. A. Kuijlen. The principal investigator is Jos M.A. Kuijlen, MD, PhD at University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen. The trial plans to enroll 180 participants.