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Single vs Dual Implants for Distal Femur Fracture
N/A
Waitlist Available
Led By Justin Haller, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient was previously ambulatory
Operative treatment within 72 hours of presenting to the treating hospital
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
Study Summary
This trial is testing whether two implants are better than one for treating elderly patients with a type of broken thighbone.
Who is the study for?
This trial is for people over 60 who had a recent femur fracture near the knee and were walking before the injury. They must be able to get surgery within 3 days of arriving at the hospital, and their fractures should be fixable with either one or two metal supports. People with infections, severe cognitive issues, bone diseases like Paget's, very advanced Parkinson's disease, major bone loss in the femur needing grafting, other big leg fractures or blood vessel injuries can't join.Check my eligibility
What is being tested?
The study aims to compare outcomes between older adults with a specific type of leg fracture near the knee treated using either one metal support (like a plate or rod) versus two supports (a combination). The goal is to see which method helps patients recover better.See study design
What are the potential side effects?
Potential side effects from surgical implantation may include pain at the site of surgery, infection risks associated with any operation, possible damage to surrounding tissues or nerves during implant placement and complications related to healing such as improper joining of bones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was able to walk on my own before.
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I had surgery within 3 days of arriving at the hospital.
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I am 60 years old or older.
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My fracture can be fixed with one or two implants.
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I have a broken thigh bone below the midsection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mortality
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single distal femur implantExperimental Treatment1 Intervention
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Group II: Dual distal femur implantsExperimental Treatment1 Intervention
Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,672 Total Patients Enrolled
Justin Haller, M.D.Principal InvestigatorUniversity of Utah Orthopaedics
3 Previous Clinical Trials
235 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was able to walk on my own before.I had surgery within 3 days of arriving at the hospital.I am 60 years old or older.I have had a blood vessel injury.I currently have an infection.I have a history of bone diseases like Paget's.I have a fracture caused by a disease.I need a bone graft due to significant loss in my thigh bone.My fracture can be fixed with one or two implants.My condition is Stage 5 Parkinson's disease.I have a major fracture in my leg.I have a broken bone that is exposed through my skin.I have a broken thigh bone below the midsection.
Research Study Groups:
This trial has the following groups:- Group 1: Dual distal femur implants
- Group 2: Single distal femur implant
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.
If a potential patient is under 50, can they still join this research study?
"The age range for enrolment in this clinical trial is 60 to 100 years old."
Answered by AI
Does my profile fit the prerequisites for this clinical trial?
"This study is looking for 50 patients aged 60-100 that have recently suffered a fracture in their distal femur. Most importantly, the following criteria must be met: the patient must be 60 years or older, the femur fracture needs to be distal to the femoral diaphysis, the patient must have had surgery to treat the fracture within 72 hours of presenting at the hospital, the patient must have been able to walk before the injury, the fracture must be something that can be fixed with either a single or dual implant, and the patient or their power of attorney must be able to provide informed consent."
Answered by AI
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