NCT02056470

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Maxx Orthopedics Inc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Joint Pain

Interventions

Type	Name	Description
DEVICE	Freedom Total Knee	The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
DEVICE	Total Knee Replacement	total Knee replacement implant
DEVICE	Freedom Total Knee System	Total Knee replacement implant

Timeline

• Start date: 2013-09-01
• Primary completion: 2020-02-01
• Completion: 2020-03-01
• First posted: 2014-02-06
• Last updated: 2020-03-30

Locations

1 site across 1 country: United States