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Bone Graft
Intramedullary Bone Grafting for Tibial Fractures
N/A
Waitlist Available
Led By Rodolfo Zamora, MD
Research Sponsored by University of Louisville
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 6 months
Awards & highlights
Study Summary
This trial will compare two groups of patients with open tibia fractures treated with intramedullary nailing. One group will have a bone graft, while the other will not.
Who is the study for?
Adults with a specific type of broken tibia (shinbone) called an open fracture, who can have the wound closed during initial surgery and are willing to follow up for 6-9 months. Not for those under 18, pregnant women, patients with certain bone conditions or fractures, or individuals with quadriplegia or paraplegia.Check my eligibility
What is being tested?
The trial is testing if adding a bone graft made from reamed-out bone material to standard treatment helps bones heal faster in adults. Participants will be randomly divided into two groups; one receives the graft along with regular nail fixation treatment.See study design
What are the potential side effects?
Potential side effects may include pain at the graft site, infection risks associated with surgery and implantation of foreign materials, inflammation around the area where the nail and graft are placed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Union at 4 months
Radiographic Union at 6 months
Secondary outcome measures
Lower Extremity Functional Scale Score at 2 months
Lower Extremity Functional Scale Score at 4 months
Lower Extremity Functional Scale Score at 6 months
Other outcome measures
Return to work status at 2 months post injury
Return to work status at 4 months post injury
Return to work status at 6 months post injury
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Patients in this group will receive a bone graft in addition to the undergoing standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)
Group II: ControlActive Control1 Intervention
Patients in this group will undergo standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,854 Total Patients Enrolled
Rodolfo Zamora, MDPrincipal Investigator - University of Louisville
Baptist Health Louisville, Ulrf Acb Orthopedics, University Of Louisville Physicians, Inc., University of Louisville Hospital, Upa Neurosurgery
2 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have skin problems on your shin that cannot be fully closed.You are pregnant.You have a broken shinbone that can be treated with a metal rod and the fracture is classified as Gustillo I, II, or IIIa.You have a broken shinbone.You have a broken tibia bone that is not able to heal properly, or you have lost some of your bone.You are unable to move your arms and legs (quadriplegia) or unable to move your legs (paraplegia).
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are being monitored during this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research project is presently recruiting participants and was first made public on March 26 of 2020 with the most recent update occurring on December 13 2021. 130 volunteers are needed for participation in a single medical centre location."
Answered by AI
Are there any opportunities open to join this research initiative?
"Affirmative. According to the clinicaltrials.gov website, this research is actively recruiting participants with a start date of March 26th 2020 and last updated on December 13th 2021. 130 individuals are required from one location."
Answered by AI
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