NCT01721889

Brief Summary

The primary objective of this pilot study is to determine the precision of post-operative radiostereometric measurements for the assessment of lumbar spinal fusion. This study will also determine the potential for RSA as a more precise and accurate means for assessment of lumbar spinal fusion and diagnosis of pseudarthrosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

October 31, 2012

Last Update Submit

June 10, 2013

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Intervertebral motion post-op lumbar fusion

    The purpose of this radiostereometric analysis (RSA) evaluation is to measure relative intervertebral motion in lumbar spinal fusions. Two RSA loading provocation protocols will be employed in this study; sitting and supine extension. Both loading protocols will be compard to a standard supine position which is used as an unloaded baseline protocol. Induced intervetebral motion sets will be calculated between the two loaded states, sitting and supine extension, and the unloaded state. The RSA micromotion results will be calculated and reported as translations and rotations about the three anatomic axes, maximum total point motion (MTPM) will be calculated as well.

    2 years

Study Arms (3)

Radiostereometric analysis - Intact fusion

Clinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging)

Radiation: Radiostereometric Analysis

Radiostereometric analysis - Symptomatic pseudoarthrosis

Definitive clinical evidence of pseudarthrosis (not fused, ˃ 2 degrees angular motion or absence of bone bridge) and scheduled for surgical exploration

Radiation: Radiostereometric Analysis

Radiostereometric analysis - Asymptomatic pseudoarthrosis

Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration.

Radiation: Radiostereometric Analysis

Interventions

Radiostereometric AnalysisRADIATION

The radiostereometric (RSA) patient exam (flexion and extension RSA images) presents additional radiation exposure to the patient above standard of care (additional radiographs). Assuming 120kV, using three protocols (two loaded and one unloaded) per RSA exam results in a typical effective dose of approximately 2.04mSv per exam(single lumbar spine RSA at 120kV yields 0.68mSv,). HBI recommends using 140kV for lumbar spine RSA and has conducted simulations to estimate the effective dose using higher kV settings. 140kV reduces the effective dose from 0.68mSv per spine RSA to 0.2mSV, resulting in a total effective dose per RSA exam of 0.6mSv. In comparison, the estimated effective dose for a single standard lumbar spine x-ray is 1.2mSv. This additional radiation exposure is considered to be minimal risk in consideration of the number of planar x-rays the patient will undergo as part of standard care, as well as average background radiation received by humans per year (3.1mSv).

Radiostereometric analysis - Asymptomatic pseudoarthrosisRadiostereometric analysis - Intact fusionRadiostereometric analysis - Symptomatic pseudoarthrosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18 and 75 that are diagnosed with lumbar DDD (L1-L5, and also L5-S1) and scheduled for one or multi level spinal fusion surgery will be recruited for the study.

You may qualify if:

  • Symptomatic degenerative disc disease of the lumbar spine indication surgical intervention
  • Scheduled to undergo lumbar fusion surgery
  • Patients between the ages of 18 and 75
  • Ability to give informed consent

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OAD Orthopaedics

Warrenville, Illinois, 60555, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • John Andreshak, MD

    OAD Orthopaedics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjorie Delaney, APN

CONTACT

630-225-2554marjorie.delaney@oadortho.com

John Andreshak, MD

CONTACT

630-225-2663john.andreshak@oadortho.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 6, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)