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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03052790
Enrollment
0
Registered
2017-02-14
Start date
2018-07-01
Completion date
2019-12-01
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis

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.

Interventions

PROCEDUREmanually 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.

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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)within 2 weeks before surgery, within one month of surgeryThe absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.

Secondary

MeasureTime frameDescription
Pain as assessed by the PROMIS 10 measurement systemwithin 2 weeks before surgeryPatient-Reported Outcomes Measurement Information System (PROMIS)
Function as assessed by the PROMIS 10 measurement systemwithin 2 weeks before surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement systemwithin 2 weeks before surgery
Pain as assessed by a Visual Analogue Scale (VAS)within 2 weeks before surgeryPain is rated on a scale of 0 to 10, with 10 being the highest level of pain.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026