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

NCT04912973 | Unknown FDA Device

• 1 other identifier: B3222020000151
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Gait Analysis - walking speed - faster is better

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

  2 year

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

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

  2 year

Secondary Outcomes (1)

• 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 Arms (2)

inverse Kinematic Alignment

ACTIVE COMPARATOR

Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement

adjusted Mechanical Alignment

ACTIVE COMPARATOR

Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement

Interventions

Robotically Assisted Total Knee Arthroplasty - Knee Replacement PROCEDURE

Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy

Also known as: Triathlon Total Knee System of Stryker with Mako Robotic Platform, Triathlon Total Knee Replacement of Stryker

adjusted Mechanical Alignment; inverse Kinematic Alignment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philip Winnock de Grave, MD: lead
• AZ Delta: collaborator

Study Sites (1)

AZDelta

Roeselare, 8800, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 3, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)