Total Knee Arthroplasty for Knee Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial monitors the safety and effectiveness of the Maxx Freedom Total Knee System, a knee replacement device, after its market release. It focuses on patients scheduled for their first total knee replacement (TKA) after non-surgical treatments have failed. Suitable participants have not undergone prior knee replacements or major knee surgeries related to tumors or injuries. As a Phase 4 trial, this study involves an FDA-approved device and aims to understand its benefits for a broader patient population.
Will I have to stop taking my current medications?
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 Maxx Freedom Total Knee System?
Research has shown that the Freedom Total Knee System is generally well-received by patients. One study found that patients experienced excellent improvements in movement and quality of life at least three years after surgery, indicating they adapted well to the implant over time. Additionally, the USFDA has approved this knee system, confirming it meets safety standards for use in people. Another study examined the knee system's safety and effectiveness, confirming it works well without major problems. Overall, the evidence suggests that the Freedom Total Knee System is safe for patients needing knee replacement.12345
Why are researchers enthusiastic about this study treatment?
The Maxx Freedom Total Knee System stands out because it offers a more personalized approach to knee replacement. Unlike traditional knee replacements that often use a one-size-fits-all model, this system is designed to better match the individual anatomy of each patient, potentially leading to improved comfort and mobility. Researchers are excited because this tailored fit could mean faster recovery times and longer-lasting results compared to the standard knee replacement options available today.
What evidence suggests that the Maxx Freedom Total Knee System is effective for primary TKA?
Research has shown that the Maxx Freedom Total Knee System, which participants in this trial will receive, can improve knee function. One study found that patients achieved a good range of motion, averaging about 120 degrees, with 61% reporting no pain after surgery. Another study followed patients for ten years and confirmed the system's design as effective in achieving these positive results. Additionally, studies indicate that people experienced better quality of life and improved knee scores after the procedure. These findings suggest that the Maxx Freedom Total Knee System effectively enhances knee function and reduces pain for those undergoing total knee replacement.14678
Who Is on the Research Team?
Asit Shah, MD, PhD
Principal Investigator
Chief of Orthopedics, Englewood Hospital
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
Participants receive the Maxx Freedom Total Knee System for primary TKA
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Total Knee Arthroplasty
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
TARGETED PATIENTS Adult male and female patients greater than 18 years of age Candidate for primary TKA GENERAL EXCLUSIONS Active infection Revision / conversion TKA (Prior UKA or HTO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maxx Orthopedics Inc
Lead Sponsor
Citations
Clinical Evaluation of Efficacy and Performance of All-Poly ...
Freedom Total Knee System evaluated by this study showed very good results in terms of the range of motion (119.8°±11.05), no pain (61%), and no ...
2.
maxxortho.com
maxxortho.com/wp-content/uploads/2024/12/MXO_TB00012_R01_TechBrief_10YearStudy_04apr2023a_WEB-1-1.pdfThe Freedom Total Knee® System: Ten-Year Follow-Up ...
The purpose of this study was to report the early results of a primary TKA system in support of the component design characteristics for achievement of.
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT02056470?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(freedom)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL))&rank=1Evaluate the Safety, Functionality, and the Quality of Life ...
The study objective is to assess the safety, functionality, and survivorship of the Freedom Knee System through a multi-center clinical trial. Study endpoints ...
Comparative mid-term evaluation of unilateral and bilateral ...
This PMS study concluded that unilateral and bilateral TKA using MBC yielded good outcomes and there was a significant improvement in ROM, KSS scores and QoL
5.
journaloei.scholasticahq.com
journaloei.scholasticahq.com/article/125430-continuation-of-a-currently-available-primary-total-knee-arthroplasty-system-design-10-year-follow-up-of-earlier-studies-at-2-and-5-yearsContinuation of a Currently Available Primary Total Knee ...
The purpose of this study was to advance the knowledge base of the performance of Freedom® Knee system through the continuous monitoring of a previously ...
Freedom® Primary Knee System
The Freedom® Primary Knee System is the total knee arthroplasty solution, giving patients optimal high-flexion motion while conserving bone.
March 13, 2025 Maxx Orthopedics, Inc. Donald Guthner ...
The Freedom Total Knee System All-Poly Tibial Plate implants have been developed with the desire to expand upon the already clinically.
FREEDOM® Orthopedic Knee Implant System
The Freedom Total Knee System is the first USFDA-approved knee system with 7 tangential radii, resulting in excellent implant-to-bone fit.
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