Recruiting

Decompression vs. FusionDecompression Versus Decompression and Fusion

Sponsor:

Massachusetts General Hospital

Code:

NCT04542720

Conditions

Adjacent Segment Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational: Decompression

Observational: Extension Fusion

Study Details

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.

Conditions

Adjacent Segment Disease

Study ID

NCT04542720

Start date

Sep 1, 2020

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

96 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational: Decompression

Eligible patients may have a preference for the surgical procedure they wish to have. In these instances, they may choose to undergo a decompression alone or a decompression with extension of fusion. These patients are eligible for the study and will be enrolled under observational arms. This arm refers to the decompression alone observational study arm.

Observational: Extension Fusion

Interventions

Observational: Decompression

Patients will undergo decompression alone of the supradjacent level. The surgical technique will be surgeon dependent. All surgeons will be encouraged to avoid damaging facet joints above the fusion mass, retaining 50% of the pars of the decompressed level and performing as minimal of a medial facetectomy as necessary.

Observational: Extension Fusion

Patients will undergo decompression and extension of posterior instrumentation and fusion. This may or may not include exchange of pre-existing instrumentation. The use of interbody cages will be left to the discretion of the treating surgeon. The purpose of introducing this heterogeneity is to increase the generalizability of the trial results. The fusion cohort will not utilize bone morphogenetic protein products.

Primary outcome measure

Global Health, Physical [ Time Frame: 3 months, 6 months, 1 year, and 2 years post-operation ]
Physical Function, short form 10a (SF10a) [ Time Frame: 3 months, 6 months, 1 year, and 2 years post-operation ]

Central Contacts and Locations

Central contacts

Daniel Tobert, MD

617-643-3932 DTOBERT@mgb.org

Amelia L Osgood, BA

617-643-3932 aosgood2@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Daniel Tobert, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-21.