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Decompression Versus Decompression and Fusion

Massachusetts General Hospital · NCT04542720

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
96
US sites recruiting
1
Study start
September 1, 2020
Record last updated
November 21, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Observational: Decompression; Observational: Extension Fusion

Conditions: Adjacent Segment Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Daniel Tobert, MD

Study contacts (from the official record)

  • Daniel Tobert, MD · 617-643-3932 · DTOBERT@mgb.org
  • Amelia L Osgood, BA · 617-643-3932 · aosgood2@mgh.harvard.edu
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Decompression Versus Decompression and Fusion (NCT04542720) | Bored Studies