Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04542720

Decompression Versus Decompression and Fusion

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adjacent Segment Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Daniel Tobert, MD

CONTACT

Daniel Tobert, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational: Decompression

Procedure

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

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 outcomes

  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 outcomes

  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) utilized more than 90 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia L Osgood, BA

CONTACT

[email protected]

617-643-3932

Daniel Tobert, MD

CONTACT

[email protected]

617-643-3932

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2020
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.