Application of Knee Measurements on 3D CT in TKR
June 19, 2024 updated by: Vo Sy Quyen Nang, Vinmec Healthcare System
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hai Ba Trung
-
Hanoi, Hai Ba Trung, Vietnam, 100000
- Vinmec Times City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Knee with OA
Underwent Total Knee replacement Surgery, using 3D printed PSI,
|
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
Time Frame: 30/06/2023
|
Position of implants compare to the plan on CT, measure the discrepancies by degree
|
30/06/2023
|
|
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
|
30/06/2024
|
|
Clinical outcome, by surgeon's evaluating
Time Frame: 30/06/2024
|
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
Time Frame: 30/06/2023
|
Size of knee on stimulated bone resection slice, AP and ML dimension in millimeters
|
30/06/2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Duong Dinh Toan, Ph.D, Hanoi Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.