Antibiotic Coated Intramedullary Nail for Segond Fracture

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Atrium Health Carolinas Medical Center, Charlotte, NC
Segond Fracture+4 More
Antibiotic coated intramedullary Nail - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

Eligible Conditions

  • Segond Fracture
  • Osteomyelitis
  • Fracture

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Segond Fracture

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6 weeks, 3 months, 6 months and 12 months

12 months
Adverse Events
Deep surgical site infection
Radiographic Union
Month 12
Return to work/duty

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Segond Fracture

Trial Design

2 Treatment Groups

Antibiotic Coated Intramedullary Nail
1 of 2
Intramedullary Nail
1 of 2
Active Control

484 Total Participants · 2 Treatment Groups

Primary Treatment: Antibiotic Coated Intramedullary Nail · No Placebo Group · Phase 4

Antibiotic Coated Intramedullary Nail
Drug
ActiveComparator Group · 1 Intervention: Antibiotic coated intramedullary Nail · Intervention Types: Drug
Intramedullary Nail
Other
ActiveComparator Group · 1 Intervention: Standard Intramedullary Nail · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 3 months, 6 months and 12 months
Closest Location: Atrium Health Carolinas Medical Center · Charlotte, NC
Photo of charlotte 1Photo of charlotte 2Photo of charlotte 3
2021First Recorded Clinical Trial
0 TrialsResearching Segond Fracture
2 CompletedClinical Trials

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,100 Previous Clinical Trials
1,128,541 Total Patients Enrolled
Joseph Hsu, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
230 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be aged 18 years or older.\n
You have a Gustillo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References