Radiostereometric Analysis of Spine Arthrodesis

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Radiation: Radiostereometric Analysis

• Registration Number: NCT01721889
• Lead Sponsor: OAD Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-31
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11
• Primary Completion: 2015-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiostereometric analysis - Symptomatic pseudoarthrosis	Radiostereometric Analysis	Definitive clinical evidence of pseudarthrosis (not fused, ˃ 2 degrees angular motion or absence of bone bridge) and scheduled for surgical exploration
Radiostereometric analysis - Intact fusion	Radiostereometric Analysis	Clinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging)
Radiostereometric analysis - Asymptomatic pseudoarthrosis	Radiostereometric Analysis	Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration.

Primary Outcome Measures

Name	Time	Method
Intervertebral motion post-op lumbar fusion	2 years	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.

Trial Locations

Locations (1)

OAD Orthopaedics; 🇺🇸 Warrenville, Illinois, United States