Maxx Ortho
Norristown, Pennsylvania, 19403, United States
NCT Number: NCT02056470
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data for:
1. Range of Motion 2. Quality of Life measurements using Knee Society Scale (KSS) 3. Survivorship as defined by 'No Revision' of baseline implant 4. Quality of Life measurements using the WOMAC Score
Looking for future studies?
Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Norristown, Pennsylvania, 19403, United States
The clinical study will involve a series of evaluations performed by your surgeon. These examinations are consistent with the normal surgeon care as part of Total Knee Replacement surgery. The study objective is to assess the safety, functionality, and survivorship of the Freedom Knee System through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery (baseline) versus Post-Surgery data for Range of Motion and Flexion, Quality of Life (KSS), and survivorship (defined by 'no revisions'). Additionally, the structural integrity will be evaluated based on the x-ray performed 36-months after knee replacement.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
Other names: Freedom Total Knee System
total Knee replacement implant
Other names: Freedom Knee
Total Knee replacement implant
Other names: Freedom Knee
Time frame: 3 years
The study is hoping to assess the safety of the implant by looking at the incident of revisions to the implant post surgery up to and including 3 years
Maxx Orthopedics Inc
Industry
A Prospective, Multicenter, Single Arm Adaptive-Design Study to Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06351917
Knee Joint Pain
Brisbane, Queensland, Australia
View Trial Details