Optetrak Knee System for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on gathering more information about the Optetrak Total Knee System, used in knee replacement surgeries. The goal is to assess the effectiveness and safety of this knee system by collecting data from individuals who have received or need a knee replacement. It suits those advised to undergo a knee replacement or who have already had one with an Exactech device. Participants should not have serious infections or material allergies related to the knee system. As a Phase 4 trial, this research aims to understand how the already FDA-approved and proven effective knee system benefits more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the Optetrak Total Knee System?
Research shows that the Optetrak Total Knee System is used in knee replacement surgeries for adults needing a new knee joint. The FDA has approved this system, indicating it has passed various safety checks.
Previous studies have found that the system is generally well-tolerated. However, like any medical device, issues can arise. Some patients have experienced problems, though these are uncommon. The system should not be used in individuals with active infections or weak bones.
Overall, the Optetrak Total Knee System has a history of safety for most patients needing knee replacement. Prospective trial participants should discuss potential risks with their doctor.12345Why are researchers enthusiastic about this study treatment?
The Optetrak Total Knee System is unique because it aims to enhance the outcomes of knee arthroplasty by providing improved alignment and stability, potentially leading to better joint function and longevity. Unlike traditional knee replacement systems, which often focus on standard implant designs, the Optetrak system is designed with advanced materials and precision instrumentation, which may offer a more personalized fit for patients. Researchers are excited about this treatment because it could reduce recovery time and improve the overall quality of life for those undergoing knee replacements.
What is the effectiveness track record for the Optetrak Total Knee System?
Research has shown that the Optetrak Total Knee System performs well in knee replacements. In one study, 81% of patients achieved excellent or good knee function post-surgery. Another study found that 97.2% of these knee replacements lasted at least 10 years without requiring additional surgery. These findings indicate that the Optetrak is both reliable and long-lasting. Overall, the evidence strongly supports its use for enhancing knee function and durability.46789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive the Optetrak knee prosthesis as part of standard care
Follow-up
Participants are monitored for safety and effectiveness after receiving the knee prosthesis
What Are the Treatments Tested in This Trial?
Interventions
- Optetrak Total Knee System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exactech
Lead Sponsor
Citations
Clinical and functional results of Optetrack™ Total Knee ...
The aim of the study was to report the functional results of a group of Optetrack™. TKA patients over a period between 6 and 13 years after ...
The Right Track
OPTETRAK CLINICAL RESULTS. Surgeons around the world have documented excellent results with the Optetrak knee system. Dr. Ivan Gradisar reported excellent ...
Midterm Results of Optetrak Posterior-Stabilized Total ...
Of the patients, 81% had an excellent or good result, 14.9% had a fair result, and 4.1% had a poor result. Using the Kaplan-Meier method, we obtained a 91.3% ...
Evaluating and Treating Patients With a Recalled Exactech ...
In another study, the survival rate for the Optetrak system was 97.2% at 10 years [5].
Study to Assess Exactech's Guided Personalized Surgery ...
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the ...
Exactech® Optetrak® Logic® CR Knee System
The OPTETRAK Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement ...
Exactech@ Optetrak@ Total Knee System Line Extension
The OPTETRAK' Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate ...
a comparative study of safety notices and register outliers
55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of ...
FEB 1. 3 2004Exactech Optetrak® Total Knee System
The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow ...
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