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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04542720
Study type Observational
Source Massachusetts General Hospital
Contact Daniel Tobert, MD
Phone 617-643-3932
Email DTOBERT@mgb.org
Status Recruiting
Phase
Start date September 1, 2020
Completion date September 2026

See also
  Status Clinical Trial Phase
Completed NCT04320043 - Adjacent Segment Disease After Anterior Cervical Decompression Surgery
Not yet recruiting NCT04970862 - Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration