Adjacent Segment Disease
Conditions
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.
Interventions
PROCEDUREObservational: 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.
PROCEDUREObservational: 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.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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/ |
| 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) |
Countries
United States
Contacts
Primary ContactDaniel Tobert, MD
Backup ContactAmelia L Osgood, BA
Outcome results
None listed