Decompression Versus Decompression and Fusion

ConditionAdjacent Segment Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Adult patients at least one year removed from a previous instrumented posterior lumbar fusion will be considered for inclusion in this trial. Any prior posterior fusion involving L2 to the sacrum will be included, whether single-level or multilevel. Patients with symptoms related to central and lateral recess at the suprajacent level that have persisted despite at least six weeks of non-operative therapy modalities will be eligible.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Observational: Decompression
Procedure/Surgery
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
Procedure/Surgery
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.

Treatment groups

96 Participants

are divided into 2 treatment groups

Group A: Observational: Decompression1 intervention

Group B: Observational: Extension Fusion1 intervention

Trial outcomes

Primary outcomes

Global Health, Physical

Scored by Patient-Reported Outcomes Measurement Information System (PROMIS): 16-68 (higher score = better outcome)

Time frame