Comparison of Clinical Outcome and Alignment of NAVIO Total Knee Arthroplasty and Conventional Total Knee Arthroplasty A Prospective, Randomized, Controlled, Single Blind Study
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray
• High need to obtain pain relief and improve function
• Above 18 years old
• Able and willing to follow instructions
• Informed consent
Locations
Other Locations
Belgium
Orthopaedic Association Sint-Trudo Hospital
RECRUITING
Sint-truiden
Contact Information
Primary
Peter Bollars, Dr.
peter.bollars@stzh.be
+3211 33 42 86
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2030-02
Participants
Target number of participants: 180
Treatments
Active_comparator: Conventional total knee arthroplasty
conventional total knee arthroplasty with standard intramedullary alignment guide
Active_comparator: NAVIO total knee arthroplasty
NAVIO assisted total knee arthroplasty
Related Therapeutic Areas
Sponsors
Leads: Sint-Trudo Hospital