Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty

Knee Arthritis Clinical Trial

Official title:

Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03052790
• Other study ID #: HSC-MS-16-1096
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patients who have knee pain and are candidates for total knee arthroplasty

• Patients able to consent to be included in the study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Arthritis

Intervention

Procedure:
• manually instrumented total knee arthroplasty
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.

Device:
• robotic assisted total knee arthroplasty
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	within 2 weeks before surgery
Secondary	Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	3 months after surgery
Secondary	Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	6 months after surgery
Secondary	Pain as assessed by the PROMIS 10 measurement system	Patient-Reported Outcomes Measurement Information System (PROMIS)	1 year after surgery
Secondary	Function as assessed by the PROMIS 10 measurement system		within 2 weeks before surgery
Secondary	Function as assessed by the PROMIS 10 measurement system		3 months after surgery
Secondary	Function as assessed by the PROMIS 10 measurement system		6 months after surgery
Secondary	Function as assessed by the PROMIS 10 measurement system		1 year after surgery
Secondary	Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		within 2 weeks before surgery
Secondary	Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		3 months after surgery
Secondary	Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		6 months after surgery
Secondary	Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system		1 year after surgery
Secondary	Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	within 2 weeks before surgery
Secondary	Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	3 months after surgery
Secondary	Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	6 months after surgery
Secondary	Pain as assessed by a Visual Analogue Scale (VAS)	Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.	1 year after surgery