Comparing decompression surgery to decompression with fusion for adjacent segment disease
Official title: Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease
Run by Massachusetts General Hospital · NCT04542720 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT04542720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.