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Decompression Versus Decompression and Fusion

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ClinicalTrials.gov Identifier: NCT04542720
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Daniel G.Tobert, M.D., Massachusetts General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adjacent Segment Disease Procedure: Decompression Procedure: Extension Fusion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be identified for inclusion by surgeons who are co-investigators in this trial. All eligible patients will be submitted to the study coordinator and randomized to a surgical treatment cohort (exposure) regardless of their enrollment status to capture the eligibility to enrollment ratio. Randomization will be performed in random permuted blocks of 4 within strata. One stratum will be prior single level lumbar fusion or multilevel fusions. This randomization technique was selected given the relatively low sample size (N<1000) and concern for unbalanced cohorts arising in relation to prior number of levels fused. The study coordinator will secondarily confirm eligibility of those enrolled. Baseline demographic (age, sex, ethnicity), clinical (BMI, Charlson co-morbidity index, number and levels fused prior), and radiographic data (disc height, disc angle, facet angle) will be collected in a standardized fashion on all patients.
Masking: Single (Outcomes Assessor)
Masking Description: This is a single blinded study. The patient and surgeon will both know what cohort the patient belongs to. The outcomes assessor will not know which cohort each patient belongs to when assessing statistics. This will allow for a non-biased conclusion to which treatment cohort, decompression or decompression and fusion, provides a better outcome.
Primary Purpose: Treatment
Official Title: Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Decompression Procedure: 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.
Active Comparator: Extension Fusion Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Global Health, Physical [ Time Frame: 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)

  2. Physical Function, short form 10a (SF10a) [ Time Frame: 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 Outcome Measures :
  1. Global Health, Mental [ Time Frame: 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)

  2. Pain intensity, short form 3a (SF3a) [ Time Frame: 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)

  3. Anxiety, short form 4a (SF4a) [ Time Frame: 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)

  4. Depression, short form 4a (SF4a) [ Time Frame: 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)

  5. Pain interference, short form 4a (SF4a) [ Time Frame: 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)

  6. Post-operative complication [ Time Frame: 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/

  7. Hospital length of stay [ Time Frame: 3 months, 6 months, 1 year, and 2 years post-operation ]
    Scored by how long the patient is in the hospital after operation.

  8. Post-operative narcotic utilization [ Time Frame: 3 months, 6 months, 1 year, and 2 years post-operation ]
    Scored by morphine milligram equivalents (MME) over 90 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542720


Contacts
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Contact: Daniel Tobert, MD 617-643-3932 DTOBERT@PARTNERS.ORG

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel Tobert, MD         
Principal Investigator: Daniel Tobert, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Daniel Tobert, MD Massachusetts General Hospital
More Information
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Publications:

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Responsible Party: Daniel G.Tobert, M.D., Principle Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04542720    
Other Study ID Numbers: 2020P000603
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No