Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion

Launched by JOS M. A. KUIJLEN · Sep 9, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing three different surgical methods for treating certain types of lower back problems, specifically degenerative spondylolisthesis and spondylolytic spondylolisthesis. These conditions involve a misalignment of the spine that can cause pain in the legs and lower back. The study will look at the short-term outcomes of using a newer technique called Cortical Bone Trajectory (CBT) compared to traditional open surgery and a less invasive method. A total of 180 patients will be involved, and they will be monitored for up to six weeks after their surgery.

To participate in this trial, individuals must be between 18 and 75 years old and have specific types of spondylolisthesis that have caused ongoing pain for more than three months. Some people may not be eligible if they have had previous spine surgery at the same level, have osteoporosis, or have certain other medical conditions. Participants can expect to receive one of the three surgical approaches and will be followed closely for their recovery. This study aims to provide valuable information on which surgical technique may lead to better outcomes for patients with these spine issues.

Gender

ALL

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)