Trials / Completed
CompletedNCT04307251
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 168 (actual)
- Sponsor
- Navamindradhiraj University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Navio™ Robotics-assisted Surgical System, LEGION Total Knee System | Robotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy. |
| DEVICE | Conventional, LEGION Total Knee System | Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. |
Timeline
- Start date
- 2020-03-23
- Primary completion
- 2021-01-30
- Completion
- 2021-02-25
- First posted
- 2020-03-13
- Last updated
- 2022-04-22
Locations
1 site across 1 country: Thailand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04307251. Inclusion in this directory is not an endorsement.