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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02056470
Study type Interventional
Source Maxx Orthopedics Inc
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date March 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06351917 - Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain Phase 4