Trials / Completed
CompletedNCT03227692
Persona TKA With iASSIST Knee System and iASSIST Knee System
Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
Detailed description
Objective： To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system. Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group. Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Persona Knee System | Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. |
| PROCEDURE | Total Knee Arthroplasty | Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. |
| DEVICE | iAssist Knee | Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. |
Timeline
- Start date
- 2017-08-18
- Primary completion
- 2019-11-14
- Completion
- 2019-12-02
- First posted
- 2017-07-24
- Last updated
- 2020-07-02
- Results posted
- 2020-03-19
Locations
3 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03227692. Inclusion in this directory is not an endorsement.