Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System

Study Overview
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Brief Summary
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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: Range of Motion Quality of Life measurements using Knee Society Scale (KSS) Survivorship as defined by 'No Revision' of baseline implant Quality of Life measurements using the WOMAC Score

Detailed Description
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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.

Official Title
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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

Conditions
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Knee Joint Pain

Intervention / Treatment
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* Device: Freedom Total Knee
* Device: Total Knee Replacement
* Device: Freedom Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females 40-80 years of age Patients requiring knee prosthesis, and have been evaluated as appropriate candidates for aTKA by their orthopedic surgeon Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation Exclusion Criteria: Previous major knee replacement of the affected knee joint Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, nueropathic joints) Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI > 35) Patients who are found to be non-compliant by their physician Patients with or having; malignancy - active malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus. The patient has a neuromuscular or neurosensory deficit. Female patients planning a pregnancy during the course of the study. Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. Varus or valgus deformity > 20 degrees

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freedom Total Knee Replacement<br>Freedom Total Knee | Device: Freedom Total Knee<br>* The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement<br>* Other names: Freedom Total Knee System;Device: Total Knee Replacement<br>* total Knee replacement implant<br>* Other names: Freedom Knee;Device: Freedom Total Knee System<br>* Total Knee replacement implant<br>* Other names: Freedom Knee;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years |