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Difference in Patellar Tracking Before and After Journey II BCS Total Knee Arthroplasty, Evaluated With 4D CT Imaging

NCT05824533 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-04-11

No results posted yet for this study

Summary

The current proposal aims to investigate the patellar tracking in adult patients receiving Journey II Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA) before and one year after surgery, positioned with the CORI Robotics System instrumentation. The hypothesis is that less change in patella tracking before and after surgery will lead to less anterior knee pain complaints. Patella tracking is investigated using 4Dimensional Computer Tomography (4D CT) imaging.

Researchers will compare the group of participants that will receive a patella onlay button with the group that will not receive a patella onlay button with their TKA to see if there is a difference in motion and pain experienced by the participants.

Conditions

  • Knee
  • Replacement
  • Arthroplasty

Interventions

DEVICE

onlay patella button

Total knee arthroplasty (TKA) with a patella onlay button placed with a CORI Robotics System based on pre-operative 4DCT-imaging.

PROCEDURE

Conventional procedure; NO onlay patella button

Total knee arthroplasty (TKA) placed with a CORI Robotics System based on pre-operative 4DCT-imaging.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Treant, the Netherlands

    collaborator UNKNOWN

  • Sebastiaan van de Groes

    lead OTHER

Principal Investigators

  • Sebastiaan van de Groes, MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2024-02-21
Completion
2024-02-21

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824533 on ClinicalTrials.gov