Application of Knee Measurements on 3D CT in TKR

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

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Disease
• Intervention / Treatment: Procedure: Total knee replacement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Vietnam
  • Hai Ba Trung
    • Hanoi, Hai Ba Trung, Vietnam, 100000
      • Vinmec Times City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with severe osteoarthritis of the knee who underwent primary TKA

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee with OA; Underwent Total Knee replacement Surgery, using 3D printed PSI,	Procedure: Total knee replacement; Mechanical Alignment Using PSI Pre and post-operative CT Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiology outcome	Position of implants compare to the plan on CT, measure the discrepancies by degree	30/06/2023
Clinical outcome, self-administered questionnaire	Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, from 0-96, lower is better	30/06/2024
Clinical outcome, by surgeon's evaluating	The 2011 Knee Society Scoring System, from 0 to 100, higher is better	30/06/2024

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AP-ML dimesion	Size of knee on stimulated bone resection slice, AP and ML dimension in millimeters	30/06/2023

Collaborators and Investigators

• Sponsor: Vinmec Healthcare System
• Investigators: Study Chair: Duong Dinh Toan, Ph.D, Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: VOSCknee3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No