Study Stopped
lack of funding
Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 4, 2019
April 1, 2019
1 year
February 9, 2017
April 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)
The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.
within 2 weeks before surgery, within one month of surgery
Secondary Outcomes (16)
Pain as assessed by the PROMIS 10 measurement system
within 2 weeks before surgery
Pain as assessed by the PROMIS 10 measurement system
3 months after surgery
Pain as assessed by the PROMIS 10 measurement system
6 months after surgery
Pain as assessed by the PROMIS 10 measurement system
1 year after surgery
Function as assessed by the PROMIS 10 measurement system
within 2 weeks before surgery
- +11 more secondary outcomes
Study Arms (2)
manually instrumented total knee arthroplasty
ACTIVE COMPARATORManually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.
robotic assisted total knee arthroplasty
EXPERIMENTALRobotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.
Interventions
Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.
Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.
Eligibility Criteria
You may qualify if:
- Patients who have knee pain and are candidates for total knee arthroplasty
- Patients able to consent to be included in the study
You may not qualify if:
- Patients with previous total or partial knee arthroplasty in need of revision surgery
- Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 70043, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Freedhand, MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 14, 2017
Study Start
July 1, 2018
Primary Completion
July 1, 2019
Study Completion
December 1, 2019
Last Updated
April 4, 2019
Record last verified: 2019-04