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External Fixation System
FastFrame External Fixation for Broken Bones
N/A
Recruiting
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The FastFrame External Fixation System - Damage Control Kit is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
Patient must be 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 weeks postoperative
Awards & highlights
Study Summary
This trialwill test how safe and effective a medical device is for broken bones.
Who is the study for?
This trial is for adults over 18 who need the FastFrame External Fixation System for knee-related fractures, specifically around or between the femur and tibia. It's not suitable for prisoners, those unable to consent or follow instructions due to mental conditions, individuals with poor skin/bone health, active infections, pregnant/breastfeeding women, or substance abusers.Check my eligibility
What is being tested?
The study tests the safety and performance of two kits: Knee Spanning and Damage Control from the FastFrame External Fixation System. These are used for temporary stabilization of severe bone fractures near or in the knee when surgery isn't an option.See study design
What are the potential side effects?
While specific side effects aren't listed here, external fixation systems can generally cause discomfort at pin sites, potential infection risk around where pins enter the skin, swelling or stiffness in nearby joints during use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need temporary support for a broken femur or tibia.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 weeks postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 weeks postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and incidence of device-related adverse events and device deficiencies
Secondary outcome measures
All other adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: FastFrame External Fixation System - Knee Spanning or Damage Control KitExperimental Treatment1 Intervention
The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,329 Total Patients Enrolled
Kacy Arnold, RN BMAStudy DirectorZimmer Biomet
Erin OsbornStudy DirectorZimmer Biomet
11 Previous Clinical Trials
12,351 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need stabilization for a knee fracture and cannot have open surgery.I need temporary support for a broken femur or tibia.I am 18 years old or older.The investigator believes you are currently abusing drugs or alcohol.I currently have or might have an infection.I have problems with my skin, bones, or blood vessels/nerves.I am able to understand and follow the study's requirements.You are pregnant or breastfeeding.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: FastFrame External Fixation System - Knee Spanning or Damage Control Kit
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 still opportunities for individuals to enroll in this research?
"Affirmative. Clinicaltrials.gov's data shows that this experiment, which was first published on June 18th 2021, is actively searching for participants. A total of 66 patients need to be recruited from one medical site."
Answered by AI
What is the current recruitment quota for this clinical trial?
"Affirmative. The details on clinicaltrials.gov demonstrate that recruitment for this trial is ongoing, having initially been posted on June 18th 2021 and edited most recently on October 17th 2022. 66 patients are needed across a single location."
Answered by AI
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