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Pre-Drilling vs Self-Drilling Techniques for External Fixation in Broken Bones
N/A
Waitlist Available
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-89
Lower extremity fracture/ dislocation treated with an external fixator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until pins are removed
Awards & highlights
Study Summary
This trial is testing whether or not pre-drilling holes for external fixation pins is better than not pre-drilling holes, in terms of the incidence of pin tract infection and pin loosening.
Who is the study for?
This trial is for adults aged 18-89 with a lower extremity fracture or dislocation that's being treated with an external fixator. Participants must understand English or Spanish to give informed consent. It excludes prisoners, those unable to consent, cases needing pins without skin coverage, and patients using certain circular external fixators.Check my eligibility
What is being tested?
The study is testing if pre-drilling holes before inserting external fixation pins in the legs affects the rate of pin tract infections and pin loosening compared to not pre-drilling. The goal is to see which method might be better at preventing complications after surgery.See study design
What are the potential side effects?
Potential side effects may include infection at the site where pins are inserted into the bone (pin tract infection) and loosening of these pins over time, which could affect healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 89 years old.
Select...
I had a leg fracture or dislocation treated with a brace or external device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until pins are removed
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until pins are removed
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
pin tract infection
Trial Design
2Treatment groups
Active Control
Group I: No pre-drillActive Control1 Intervention
these pins will not be pre-drilled, but will rely on the self drilling function of the pin for insertion
Group II: Pre-drillActive Control1 Intervention
These pins will be pre-drilled
Find a Location
Who is running the clinical trial?
Temple UniversityLead Sponsor
296 Previous Clinical Trials
82,695 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can speak and understand English or Spanish.I need pins placed in my body without skin covering them.I am undergoing treatment with a circular frame device on my limb.I am between 18 and 89 years old.I am unable to understand and give consent for my treatment.I had a leg fracture or dislocation treated with a brace or external device.
Research Study Groups:
This trial has the following groups:- Group 1: No pre-drill
- Group 2: Pre-drill
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.
Are there any criteria that would prohibit me from enrolling in this experiment?
"This fracture study is seeking 100 volunteers aged 18 to 89. Eligibility criteria requires that individuals fall within the aforementioned age range"
Answered by AI
Is enrollment for this trial open at the moment?
"The records hosted on clinicaltrials.gov indicate that this particular medical trial is no longer actively recruiting participants. It was initially posted in July 2009 and had its last update in January 2010, rendering it obsolete compared to the 381 other trials currently open for enrollment."
Answered by AI
Is the age restriction for this trial capped at 70 years or below?
"This trial is open to applicants between the age of 18 and 89. There are 85 trials that only consider minors, while 308 cater exclusively to seniors."
Answered by AI
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