Decompression Versus Decompression and Fusion

RecruitingOBSERVATIONAL
Enrollment

96

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2026

Conditions
Adjacent Segment Disease
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

02114

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER