Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment

Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04912973

Acronym

RATKA-CBO

Enrollment

Registered

2021-06-03

Start date

2020-01-01

Completion date

2024-01-31

Last updated

2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

total knee arthroplasty, robotic surgery, alignment, inverse kinematic alignment, mechanical alignment, gait analysis, performance testing

Brief summary

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.

Interventions

PROCEDURERobotically Assisted Total Knee Arthroplasty - Knee Replacement

Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Gait Analysis - walking speed - faster is better	2 year	Spatio Temporal Parameters are captured with infra-red camera during gait: velocity
Performance Testing - step-up step-down speed - faster is better	2 year	Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity

Secondary

Measure	Time frame	Description
Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48	baseline - 1 year - 2 year	Questionnaire - Oxford Knee Score

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026