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Bone Graft Substitute

Test for Tibial Fracture

N/A
Waitlist Available
Led By Douglas R. Dirschl, MD
Research Sponsored by BONESUPPORT AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™\|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures of the tibial diaphysis.

Eligible Conditions
  • Tibial Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of absence of deep infection at fracture site, absence of secondary procedures intended to promote fracture union, and improvement in the SF-36v2 PCS.
Serious device related adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TestExperimental Treatment2 Interventions
Tibial fracture fixation with IM Nail. Apply CERAMENT™\|G applied to bony void(s).
Group II: ControlActive Control1 Intervention
Tibial fracture fixation with IM nail.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CERAMENT|G
2017
N/A
~210
SOC treatment
2017
N/A
~210

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Who is running the clinical trial?

BONESUPPORT ABLead Sponsor
4 Previous Clinical Trials
553 Total Patients Enrolled
Douglas R. Dirschl, MDPrincipal InvestigatorThe University of Chicago Medicine
~23 spots leftby Oct 2025
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