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

Primary Purpose

Knee Arthritis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
manually instrumented total knee arthroplasty
robotic assisted total knee arthroplasty
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthritis

Eligibility Criteria

25 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

manually instrumented total knee arthroplasty

robotic assisted total knee arthroplasty

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Function as assessed by the PROMIS 10 measurement system
Function as assessed by the PROMIS 10 measurement system
Function as assessed by the PROMIS 10 measurement system
Function as assessed by the PROMIS 10 measurement system
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
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.
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.
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.
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.

Full Information

First Posted
February 9, 2017
Last Updated
April 2, 2019
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03052790
Brief Title
Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
Official Title
Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manually instrumented total knee arthroplasty
Arm Type
Active Comparator
Arm Description
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.
Arm Title
robotic assisted total knee arthroplasty
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
manually instrumented total knee arthroplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
robotic assisted total knee arthroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)
Description
The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.
Time Frame
within 2 weeks before surgery, within one month of surgery
Secondary Outcome Measure Information:
Title
Pain as assessed by the PROMIS 10 measurement system
Description
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
within 2 weeks before surgery
Title
Pain as assessed by the PROMIS 10 measurement system
Description
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
3 months after surgery
Title
Pain as assessed by the PROMIS 10 measurement system
Description
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
6 months after surgery
Title
Pain as assessed by the PROMIS 10 measurement system
Description
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
1 year after surgery
Title
Function as assessed by the PROMIS 10 measurement system
Time Frame
within 2 weeks before surgery
Title
Function as assessed by the PROMIS 10 measurement system
Time Frame
3 months after surgery
Title
Function as assessed by the PROMIS 10 measurement system
Time Frame
6 months after surgery
Title
Function as assessed by the PROMIS 10 measurement system
Time Frame
1 year after surgery
Title
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time Frame
within 2 weeks before surgery
Title
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time Frame
3 months after surgery
Title
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time Frame
6 months after surgery
Title
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time Frame
1 year after surgery
Title
Pain as assessed by a Visual Analogue Scale (VAS)
Description
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Time Frame
within 2 weeks before surgery
Title
Pain as assessed by a Visual Analogue Scale (VAS)
Description
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Time Frame
3 months after surgery
Title
Pain as assessed by a Visual Analogue Scale (VAS)
Description
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Time Frame
6 months after surgery
Title
Pain as assessed by a Visual Analogue Scale (VAS)
Description
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Freedhand, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
70043
Country
United States

12. IPD Sharing Statement

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

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