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NCT04542720 · ClinicalTrials.gov registry record
Decompression Versus Decompression and Fusion
A clinical trial of Adjacent Segment Disease, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 96
- Enrollment target
- 1
- Study location
NCT04542720: Recruiting study of Adjacent Segment Disease, sponsored by Massachusetts General Hospital.
NCT04542720 is a study of Adjacent Segment Disease that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 96 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04542720, a study of Adjacent Segment Disease, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 96 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)
Conditions Studied
Interventions
- PROCEDURE Observational: Decompression
- PROCEDURE Observational: Extension Fusion
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2027-09 |
What NCT04542720 shows while recruiting
NCT04542720 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target.
The record links to 1 condition, with Adjacent Segment Disease appearing as the primary indexed condition, and to 2 interventions - of which Observational: Decompression is the first listed.
NCT04542720 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04542720 about?
NCT04542720 is a clinical study titled "Decompression Versus Decompression and Fusion". 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 w...
What is the current status of trial NCT04542720?
This trial is currently recruiting. The enrollment target is 96 participants. The study started on 2020-09-01. Estimated completion is 2027-09.
What conditions does trial NCT04542720 study?
This clinical trial studies the following conditions: Adjacent Segment Disease.
What interventions are being tested in trial NCT04542720?
The interventions under investigation include: Observational: Decompression (PROCEDURE), Observational: Extension Fusion (PROCEDURE).
Who is sponsoring clinical trial NCT04542720?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04542720 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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