RECRUITING

Decompression Versus Decompression and Fusion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Decompression Versus Decompression and Fusion for Lumbar Adjacent Segment Disease

Quick Facts

Study Start:2020-09-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04542720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients at least one year removed from a previous instrumented posterior lumbar fusion
  2. * Patients with any prior posterior fusion involving L2 to the sacrum, whether single-level or multilevel
  3. * 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
  1. * Patients with previous uninstrumented lumbar fusions
  2. * Patients with traumatic, neoplastic, or infectious etiologies at the adjacent segment
  3. * Patients with prior iliac or sacroiliac fixation and those with nonunion as the primary indication for surgery
  4. * 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.
  5. * Retrolisthesis will not be a criterion for exclusion

Contacts and Locations

Study Contact

Daniel Tobert, MD
CONTACT
617-643-3932
DTOBERT@mgb.org
Theresa L Chua, BS/BA
CONTACT
617-643-3932
tchua1@mgh.harvard.edu

Principal Investigator

Daniel Tobert, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Daniel Tobert, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • Adjacent Segment Disease