Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Robot-Assisted Total Knee Arthroplasty; Procedure: Conventional Total Knee Arthroplasty

• Registration Number: NCT04724915
• Lead Sponsor: University Hospital, Ghent

Brief Summary

The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted TKA	Robot-Assisted Total Knee Arthroplasty	Patients undergoing TKA with the assistance of robot technology.
Conventional TKA	Conventional Total Knee Arthroplasty	Patients undergoing TKA with manual instrumentarium

Primary Outcome Measures

Name	Time	Method
Knee Laxity	Preoperative and postoperatively at 1 year.	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

Name	Time	Method
Change in patient reported outcome measures	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.	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	Preoperative and postoperatively at 6 weeks and 6 months.	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.
Patient reported outcome measures	Preoperative	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.
Knee laxity anteroposterior	Preoperative and postoperatively at 1 year.	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.	Postoperatively at 1 year.	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium