Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up

Not Applicable

• Conditions: Vertebral Fracture; Cement Augmentation

• Registration Number: NCT03369288
• Lead Sponsor: University of Zurich

Brief Summary

3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-05
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-30
• Primary Completion: 2019-06-28
• Study Completion: 2019-11-28

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tracer Uptake	at least 3 years after kyphoplasty	Perifokal tracer uptake at the cement-bone border

Secondary Outcome Measures

Name	Time	Method
Intravertebral Discs	at least 3 years after kyphoplasty	Tracer uptake within the intravertebral disc and morphological changes

Trial Locations

Locations (1)

Division of Trauma Surgery, University Hospital Zurich; 🇨🇭 Zürich, Switzerland