Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
Start Date
11/1/2025
Completion Date
3/1/2029
Summary
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
Detailed Description
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring. To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (\~3 patients consented / month).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Total Knee Arthroplasty
Conditions
Locations
Ascentist Healthcare
Leawood, Kansas 66211
United States
South Texas Bone & Joint Institute
San Antonio, Texas 78249
United States