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

Maxx Orthopedics

Status

Completed

Conditions

Knee Joint Pain

Treatments

Device: Freedom Total Knee

Device: Freedom Total Knee System

Device: Total Knee Replacement

Study type

Interventional

Funder types

Industry

Identifiers

NCT02056470

MO-U-101A

Details and patient eligibility

About

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

Full 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.

Enrollment

211 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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