Status:

RECRUITING

Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty

Lead Sponsor:

Medisch Centrum Latem

Collaborating Sponsors:

MicroPort Orthopedics Inc.

Conditions:

Knee Osteoarthritis

Total Knee Arthroplasty\(TKA\)

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique,...

Eligibility Criteria

Inclusion

  • Subjects from 18 years up to 85 years old
  • Patients eligible and planned for a primary Total Knee Arthroplasty
  • Patients willing to sign the informed consent form (ICF) for participating in this study
  • Indication of surgery is primary osteoarthritis

Exclusion

  • Revision knee surgery
  • Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident
  • The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee
  • Patient is participating in another clinical trial
  • Patient is not able to understand Dutch, French or English
  • Patients who did not meet all of the inclusion criteria

Key Trial Info

Start Date :

July 18 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2027

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT06891807

Start Date

July 18 2024

End Date

October 1 2027

Last Update

March 24 2025

Active Locations (1)

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Medisch Centrum Latem

Sint-Martens-Latem, Oost-Vlaanderen, Belgium, 9830

Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty | DecenTrialz