Actively Recruiting
Decompression Versus Decompression and Fusion
Led by Massachusetts General Hospital · Updated on 2025-11-21
96
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Adjacent segment disease (ASD) in the lumbar spine is a well-known sequela of lumbar fusion surgery. The annual incidence of adjacent level re-operation is approximately 3% with a ten-year prevalence of 20-30%. Frequently, the surgical treatment involves decompression of the adjacent level coupled with extension of the instrumentation and fusion. Advocates of this paradigm cite the altered kinematics and biomechanics of levels adjacent to a lumbar fusion mass. Furthermore, decompressed levels adjacent to a fused segments are associated with higher rates of ASD in retrospective studies. Yet, a retrospective review of higher quality data concluded decompression adjacent to single-level fusion provides similar outcomes compared to fusions extending across the decompressed segments. Given the conflicting data currently available, higher quality data are needed to guide surgical decision-making in ASD. The purpose of this trial is to prospectively compare decompression and decompression with fusion in patients with lumbar ASD.
CONDITIONS
Official Title
Decompression Versus Decompression and Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients with previous uninstrumented lumbar fusions
- Patients with traumatic, neoplastic, or infectious causes at the adjacent segment
- Patients with prior iliac or sacroiliac fixation and those with nonunion as the primary reason for surgery
- Patients with pre-existing instability at the supradjacent level defined as greater than 3mm change on standing lateral, flexion, and extension radiographs
- Retrolisthesis is not an exclusion criterion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
Daniel Tobert, MD
CONTACT
A
Amelia L Osgood, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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