NCT02504112

Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)

Evaluation of Zimmer® CAS PSI X-Ray Knee in Total Knee Arthroplasty (TKA): Technical Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the observational study is to assess the positioning of customized guides designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary total knee arthroplasty.

Detailed description

The proposed research is a single center, prospective, case series, and non-controlled study. One orthopedic surgeon will perform 30 primary TKAs using X-Ray PSI Knee guides, generated from X-ray. Patients who have been appropriately indicated as candidates for TKA and who meet the specified inclusion and exclusion criteria, will be informed about Zimmer® X-Ray PSI Knee technology and offered entry into the study. Informed consent, in accordance with current ethical board regulatory requirements and best practice, will be obtained from all patients.

Conditions

• Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation

Interventions

Type	Name	Description
OTHER	there is no intervention

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-07-21
• Last updated: 2018-06-25