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

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Robotically Assisted Total Knee Arthroplasty - Knee Replacement
Sponsored by
Philip Winnock de Grave, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring total knee arthroplasty, robotic surgery, alignment, inverse kinematic alignment, mechanical alignment, gait analysis, performance testing

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AZDelta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

inverse Kinematic Alignment

adjusted Mechanical Alignment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48
Questionnaire - Oxford Knee Score

Full Information

First Posted
May 17, 2021
Last Updated
July 19, 2023
Sponsor
Philip Winnock de Grave, MD
Collaborators
AZ Delta
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1. Study Identification

Unique Protocol Identification Number
NCT04912973
Brief Title
Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment
Acronym
RATKA-CBO
Official Title
Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philip Winnock de Grave, MD
Collaborators
AZ Delta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
total knee arthroplasty, robotic surgery, alignment, inverse kinematic alignment, mechanical alignment, gait analysis, performance testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inverse Kinematic Alignment
Arm Type
Active Comparator
Arm Title
adjusted Mechanical Alignment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Robotically Assisted Total Knee Arthroplasty - Knee Replacement
Other Intervention Name(s)
Triathlon Total Knee System of Stryker with Mako Robotic Platform, Triathlon Total Knee Replacement of Stryker
Intervention Description
Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy
Primary Outcome Measure Information:
Title
Gait Analysis - walking speed - faster is better
Description
Spatio Temporal Parameters are captured with infra-red camera during gait: velocity
Time Frame
2 year
Title
Performance Testing - step-up step-down speed - faster is better
Description
Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48
Description
Questionnaire - Oxford Knee Score
Time Frame
baseline - 1 year - 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
AZDelta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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