Radiostereometric Analysis of Spine Arthrodesis

OAD Orthopaedics

Status: Unknown

Conditions: Lumbar Degenerative Disc Disease

Treatments: Radiation: Radiostereometric Analysis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01721889

RSA100

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Radiostereometric analysis - Intact fusion

Description:

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

Treatment:

Radiation: Radiostereometric Analysis

Radiostereometric analysis - Symptomatic pseudoarthrosis

Description:

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

Treatment:

Radiation: Radiostereometric Analysis

Radiostereometric analysis - Asymptomatic pseudoarthrosis

Description:

Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration.

Treatment:

Radiation: Radiostereometric Analysis