RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
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|ClinicalTrials.gov Identifier: NCT03482349|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Total Knee Robotically-Assisted||Not Applicable|
Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.
A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties|
|Actual Study Start Date :||March 16, 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Total Knee Robotically-Assisted
The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.
Procedure: Total Knee Robotically-Assisted
The surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.
No Intervention: Total Knee Manual-Executed by Surgeon
Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee.
- Radiographic Parameters [ Time Frame: 1 year ]Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482349
|Contact: Lauren Coleemail@example.com|
|United States, Arizona|
|Mayo Clinic in Arizona||Recruiting|
|Scottsdale, Arizona, United States, 85259|
|Contact: Teresa Sniezek 480-342-0349 Sniezek.Teresa@mayo.edu|
|Sub-Investigator: Henry Clark|
|United States, Florida|
|Mayo Clinic Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Lori Chase 904-953-3464 Chase.firstname.lastname@example.org|
|Principal Investigator: Cameron K Ledford, M.D.|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Lauren Cole 507-266-1227 email@example.com|
|Principal Investigator: Matthew P Abdel|
|Principal Investigator:||Matthew P Abdel||Mayo Clinic|