Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing

Ghent University Hospital (UZ)

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Conventional Total Knee Arthroplasty; Procedure: Robot-Assisted Total Knee Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04724915

2018/1281bis

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Robot-assisted TKA

Experimental group

Description:

Patients undergoing TKA with the assistance of robot technology.

Treatment:

Procedure: Robot-Assisted Total Knee Arthroplasty

Conventional TKA

Active Comparator group

Description:

Patients undergoing TKA with manual instrumentarium

Treatment:

Procedure: Conventional Total Knee Arthroplasty