Decompression Versus Decompression and Fusion

Recruiting

• Conditions: Adjacent Segment Disease

• Registration Number: NCT04542720
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-27
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical Function, short form 10a (SF10a)	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 0-62 (higher score = better outcome)
Global Health, Physical	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)

Secondary Outcome Measures

Name	Time	Method
Global Health, Mental	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 21-68 (higher score = better outcome)
Anxiety, short form 4a (SF4a)	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 40-82 (higher score = better outcome)
Depression, short form 4a (SF4a)	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 41-80 (higher score = better outcome)
Pain interference, short form 4a (SF4a)	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 41-76 (higher score = better outcome)
Hospital length of stay	3 months, 6 months, 1 year, and 2 years post-operation	Scored by how long the patient is in the hospital after operation.
Post-operative narcotic utilization	3 months, 6 months, 1 year, and 2 years post-operation	Scored by morphine milligram equivalents (MME) utilized more than 90 days after surgery
Pain intensity, short form 3a (SF3a)	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 30-72 (higher score = better outcome)
Post-operative complication	3 months, 6 months, 1 year, and 2 years post-operation	Scored by Clavien-Dindo classification (Grade I, II, IIIa, IIIb, IVa, IVb, and V) defined at https://www.assessurgery.com/clavien-dindo-classification/

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States