Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing

Osteoarthritis, Knee Clinical Trial

Official title:

Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04724915
• Other study ID #: 2018/1281bis
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Conventional Total Knee Arthroplasty
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).
• Robot-Assisted Total Knee Arthroplasty
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperative and postoperatively at 1 year.
Secondary	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	Preoperative
Secondary	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.	Preoperative
Secondary	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.	Preoperative
Secondary	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.	Preoperative
Secondary	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	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.	Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary	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.	Preoperative and postoperatively at 6 weeks and 6 months.
Secondary	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.	Preoperative and postoperatively at 1 year.
Secondary	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.	Postoperatively at 1 year.