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Completed

NCT Number: NCT06475014

Application of Knee Measurements on 3D CT in TKR

A 3D Computed Tomographic Study of Vietnamese Knee Morphology for Total knee Replacement

Completed

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Disease Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vinmec Times City Hospital

Hanoi, Hai Ba Trung, 100000, Vietnam

About this study

There were controversies and inconsistent results regarding the effectiveness of PSI.

However, most authors used PSI from commercial manufacturers. From our view, the surgeon's involvement in PSI planning and design can affect the PSI's accuracy. Some other benefits of in-hospital PSI included the use of any type of implant without depending on the manufacturer's software system, faster and cheaper. Therefore, we conducted this study to evaluate the effect of in-hospital PSI in which the surgeons take part in the manufacturing job.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of knee osteoarthritis, grade III, IV
  • Underwent total knee replacement using patient-specific intrumentation
  • With pre and post-operative whole limb CT-Scanners

Exclusion criteria

  • Paticipants with valgus knee deformity,
  • A history of hip arthroplasty,
  • Large bone defect that required augments.

Treatment and study plan

Total Knee Replacement

Procedure

Mechanical Alignment Using PSI Pre and post-operative CT Scan

Primary outcomes

  1. Radiology outcome

    Time frame: 30/06/2023

    Position of implants compare to the plan on CT, measure the discrepancies by degree

  2. Clinical outcome, self-administered questionnaire

    Time frame: 30/06/2024

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, from 0-96, lower is better

  3. Clinical outcome, by surgeon's evaluating

    Time frame: 30/06/2024

    The 2011 Knee Society Scoring System, from 0 to 100, higher is better

Other outcomes

  1. AP-ML dimesion

    Time frame: 30/06/2023

    Size of knee on stimulated bone resection slice, AP and ML dimension in millimeters

Sponsors and collaborators

Lead sponsor

Vinmec Healthcare System

Other

Registry information

Official study title

Application of Knee Measurements on 3D Computed Tomography in Total Knee Replacement

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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