Decompression Versus Decompression and Fusion

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical approaches for treating adjacent segment disease (ASD) in the lower back, which can occur after previous spine surgery. The trial aims to compare the outcomes of a procedure called decompression, which relieves pressure on the nerves, versus a combined approach that includes both decompression and fusion, where the bones are joined together to provide stability. Researchers want to see which method works better for patients who still have symptoms despite trying other treatments for at least six weeks.

To participate in the trial, individuals must be adults aged 65 to 74 who have undergone a previous spine fusion surgery at least a year ago. They should have ongoing issues related to the areas above their previous surgery that haven’t improved with non-surgical treatments. However, those with certain conditions, such as a previous uninstrumented fusion or specific types of instability, will not be eligible. Participants in this trial can expect close monitoring and support throughout the study as they undergo one of the two surgical procedures being tested. This research is important because it aims to provide clearer guidance on the best surgical options for patients dealing with ASD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients at least one year removed from a previous instrumented posterior lumbar fusion
• • Patients with any prior posterior fusion involving L2 to the sacrum, whether single-level or multilevel
• • Patients with symptoms related to central and lateral recess at the supradjacent level that have persisted despite at least six weeks of non-operative therapy modalities
• Exclusion Criteria:
• • Patients with previous uninstrumented lumbar fusions
• • Patients with traumatic, neoplastic, or infectious etiologies at the adjacent segment
• • Patients with prior iliac or sacroiliac fixation and those with nonunion as the primary indication for surgery
• • Patients with pre-existing instability at the supradjacent level. The definition of instability will be determined based on standing lateral, flexion and extension plain radiographs. Patients with \>3mm of change between these views will be excluded.
• • Retrolisthesis will not be a criterion for exclusion