Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment (RATKA-CBO)

Philip Winnock de Grave, MD

Status: Active, not recruiting

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT04912973

B3222020000151

Details and patient eligibility

About

Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.

Enrollment: 80 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent must be obtained prior to any screening procedures
2. Received a primary total knee replacement (incl. patella) robotically-assisted
3. Male or female
4. Age between 50 and 80
5. Able to walk independently

Exclusion criteria

1. Revision surgery
2. Patient with a history of neurological, psychiatric or neurodegenerative disease
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
4. Other musculoskeletal lesions that may affect the gait pattern

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

inverse Kinematic Alignment

Active Comparator group

Treatment:

Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement

adjusted Mechanical Alignment

Active Comparator group

Treatment:

Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement