Comparing different techniques for lumbar spine surgery
Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
This study is testing if a new way of doing back surgery can help people feel less pain after surgery compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05538416 on ClinicalTrials.gov |
What this trial studies
This study compares three techniques for posterior lumbar interbody fusion (PLIF): cortical bone trajectory PLIF (CBT-PLIF), minimal invasive PLIF (MI-PLIF), and traditional open PLIF. It includes 180 patients, with 60 undergoing CBT-PLIF and 120 analyzed retrospectively from previous data on open and MI-PLIF. Patients will complete questionnaires before surgery and at 2 and 6 weeks postoperatively to assess pain levels and outcomes. The main goal is to determine if CBT-PLIF results in less low back pain in the short term compared to the other techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with low-grade degenerative or spondylolytic spondylolisthesis and persistent leg pain for over 3 months.
Not a fit: Patients with previous spinal fusion at the same level, severe obesity, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced pain for patients undergoing lumbar spine surgery.
How similar studies have performed: Other studies have shown varying success with different PLIF techniques, but this specific comparison of CBT-PLIF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Groningen
- Umcg — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jos M.A. Kuijlen, MD, PhD — University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen
- Study coordinator: Diane H. Steenks
- Email: d.h.steenks@umcg.nl
- Phone: 050 3617976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.