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Clinical Trials/NCT04912973
NCT04912973
Active, Not Recruiting
N/A

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

Philip Winnock de Grave, MD1 site in 1 country80 target enrollmentJanuary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Philip Winnock de Grave, MD
Enrollment
80
Locations
1
Primary Endpoint
Performance Testing - step-up step-down speed - faster is better
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
January 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Philip Winnock de Grave, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Philip Winnock de Grave, MD

Principal Investigator

AZ Delta

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Performance Testing - step-up step-down speed - faster is better

Time Frame: 2 year

Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity

Gait Analysis - walking speed - faster is better

Time Frame: 2 year

Spatio Temporal Parameters are captured with infra-red camera during gait: velocity

Secondary Outcomes

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

Study Sites (1)

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