Back to resultsEvaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Conventional Total Knee Arthroplasty
Robot-Assisted Total Knee Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- End stage osteoarthritis of the knee joint with failed conservative treatment
Exclusion Criteria:
- Previous ligament trauma of the MCL/LCL
- Previous fracture of femur or tibia
- Fixed flexion contracture > 10°
- Flexion < 110°
- Coronal deformity > 15°
- Previous infection of the knee joint
- Ligament insufficiency
- Neurologic conditions
Sites / Locations
- Ghent University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot-assisted TKA
Conventional TKA
Arm Description
Patients undergoing TKA with the assistance of robot technology.
Patients undergoing TKA with manual instrumentarium
Outcomes
Primary Outcome Measures
Knee Laxity
Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.
Secondary Outcome Measures
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems.
Alignment
Coronal alignment on xrays. The lateral distal femoral angle (LDFA) will be evaluated. This is the angle between the mechanical femoral axis and the line between the distal articular surface of the femur. Additionally the medial proximal tibial angle (MPTA) will be evaluated. This is the line between the condylar surface and the mechanical axis of the tibia on a coronal radiograph.
Knee laxity anteroposterior
Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an anteroposterior laxitymeter (GENOUROB; CE Marked). With a standardized setup, anteroposterior laxity can be obtained by measuring the anteroposterior deviation from the neutral position with up to 300 Newton of force.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
Knee kinematics in 3D obtained with fluoroscopy. Patients will be asked to perform squats, a flexion/extension movement, ascend and descend stairs. 3D motion of the prosthesis components can be obtained by projecting the 3D file of the prosthesis components onto the fluoroscopy images.
Full Information
NCT ID
NCT04724915
First Posted
January 21, 2021
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04724915
Brief Title
Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing
Official Title
Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
Masking
Outcomes Assessor
Masking Description
Masked investigators will be responsible for the data processing and analysis. Reporting will be done together with non-masked authors.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted TKA
Arm Type
Experimental
Arm Description
Patients undergoing TKA with the assistance of robot technology.
Arm Title
Conventional TKA
Arm Type
Active Comparator
Arm Description
Patients undergoing TKA with manual instrumentarium
Intervention Type
Procedure
Intervention Name(s)
Conventional Total Knee Arthroplasty
Intervention Description
People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with manual instrumentarium (jig-based).
Intervention Type
Procedure
Intervention Name(s)
Robot-Assisted Total Knee Arthroplasty
Intervention Description
People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with the help of a surgical robot.
Primary Outcome Measure Information:
Title
Knee Laxity
Description
Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.
Time Frame
Preoperative and postoperatively at 1 year.
Secondary Outcome Measure Information:
Title
Patient reported outcome measures
Description
The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems
Time Frame
Preoperative
Title
Patient reported outcome measures
Description
The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time Frame
Preoperative
Title
Patient reported outcome measures
Description
The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time Frame
Preoperative
Title
Patient reported outcome measures
Description
The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems.
Time Frame
Preoperative
Title
Change in patient reported outcome measures
Description
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time Frame
Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Change in patient reported outcome measures
Description
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time Frame
Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Change in patient reported outcome measures
Description
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time Frame
Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Change in patient reported outcome measures
Description
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time Frame
Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Change in patient reported outcome measures
Description
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems.
Time Frame
Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Title
Alignment
Description
Coronal alignment on xrays. The lateral distal femoral angle (LDFA) will be evaluated. This is the angle between the mechanical femoral axis and the line between the distal articular surface of the femur. Additionally the medial proximal tibial angle (MPTA) will be evaluated. This is the line between the condylar surface and the mechanical axis of the tibia on a coronal radiograph.
Time Frame
Preoperative and postoperatively at 6 weeks and 6 months.
Title
Knee laxity anteroposterior
Description
Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an anteroposterior laxitymeter (GENOUROB; CE Marked). With a standardized setup, anteroposterior laxity can be obtained by measuring the anteroposterior deviation from the neutral position with up to 300 Newton of force.
Time Frame
Preoperative and postoperatively at 1 year.
Title
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
Description
Knee kinematics in 3D obtained with fluoroscopy. Patients will be asked to perform squats, a flexion/extension movement, ascend and descend stairs. 3D motion of the prosthesis components can be obtained by projecting the 3D file of the prosthesis components onto the fluoroscopy images.
Time Frame
Postoperatively at 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End stage osteoarthritis of the knee joint with failed conservative treatment
Exclusion Criteria:
Previous ligament trauma of the MCL/LCL
Previous fracture of femur or tibia
Fixed flexion contracture > 10°
Flexion < 110°
Coronal deformity > 15°
Previous infection of the knee joint
Ligament insufficiency
Neurologic conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannes Vermue, MD
Phone
+3293322238
Email
Hannes.Vermue@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Victor, MD, PhD
Organizational Affiliation
UZ Ghent
Official's Role
Study Chair
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Donck
Phone
+3293325496
Email
birgit.donck@uzgent.be
First Name & Middle Initial & Last Name & Degree
Hannes Vermue, MD
First Name & Middle Initial & Last Name & Degree
Jan Victor, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nele Arnout, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing
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