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Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement

NCT04581707 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2021-01-19

No results posted yet for this study

Summary

The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.

Conditions

  • Vertebral Compression Fracture

Interventions

DEVICE

Kyphoplasty Single Balloon Catheter Allevo

Vertebral compression fractures treated with Kyphoplasty Single Balloon Catheter Allevo (Joline®) and BonOs® Inject bone cement

DEVICE

Quattroplasty Double Balloon Catheter Stop'n GO

Vertebral compression fractures treated with Stop'n GO double balloon kyphoplasty system (Joline®) and BonOs® Inject bone cement

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Lisanne Exner · University Hopsital for Orthopedics Tuebingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-06-30
Completion
2021-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581707 on ClinicalTrials.gov