Knee Joint Pain
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEFreedom Total Knee
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
DEVICETotal Knee Replacement
total Knee replacement implant
DEVICEFreedom Total Knee System
Total Knee replacement implant
Sponsors
Maxx Orthopedics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial | 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 |
Countries
United States
Outcome results
None listed