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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
211
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
total Knee replacement implant
Total Knee replacement implant
Maxx Ortho
Norristown, Pennsylvania, United States
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial
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
Time frame: 3 years
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