NCT04542720 Decompression Versus Decompression and Fusion
| NCT ID | NCT04542720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Adjacent Segment Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 96 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 96 participants in total. It began in 2020-09-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Daniel Tobert, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04542720 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adjacent Segment Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04542720 currently recruiting?
Yes, NCT04542720 is actively recruiting participants. Contact the research team at DTOBERT@mgb.org for enrollment information.
Where is the NCT04542720 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04542720 clinical trial?
NCT04542720 is sponsored by Massachusetts General Hospital. The principal investigator is Daniel Tobert, MD at Massachusetts General Hospital. The trial plans to enroll 96 participants.