Comparing decompression surgery to decompression with fusion for adjacent segment disease
Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease
This study is testing whether surgery to relieve pressure alone is just as good as surgery that also includes fusion for people dealing with problems after previous back surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04542720 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the outcomes of two surgical approaches for treating adjacent segment disease (ASD) following lumbar fusion surgery. It will evaluate patients who are at least one year post-instrumented lumbar fusion and experiencing symptoms related to adjacent levels. The study will assess whether decompression alone is as effective as decompression combined with fusion in alleviating symptoms and preventing further complications. By gathering high-quality prospective data, the study seeks to provide clearer guidance for surgical decision-making in ASD cases.
Who should consider this trial
Good fit: Ideal candidates include adults who have undergone a prior lumbar fusion and are experiencing persistent symptoms at the adjacent level despite conservative treatment.
Not a fit: Patients with previous uninstrumented lumbar fusions or those with specific conditions such as traumatic or infectious causes at the adjacent segment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective surgical approach for patients suffering from adjacent segment disease, potentially reducing the need for more invasive procedures.
How similar studies have performed: While there is conflicting data on the effectiveness of these approaches, previous studies have suggested that decompression alone may yield similar outcomes to decompression with fusion, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Tobert, MD — Massachusetts General Hospital
- Study coordinator: Daniel Tobert, MD
- Email: DTOBERT@mgb.org
- Phone: 617-643-3932
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.