NCT06475014

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

June 13, 2024

Last Update Submit

June 19, 2024

Conditions

Knee OsteoarthritisKnee Disease

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • AP-ML dimesion

    30/06/2023

Study Arms (1)

Knee with OA

Underwent Total Knee replacement Surgery, using 3D printed PSI,

Procedure: Total knee replacement

Interventions

Total knee replacementPROCEDURE

Mechanical Alignment Using PSI Pre and post-operative CT Scan

Knee with OA

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with severe osteoarthritis of the knee who underwent primary TKA

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinmec Times City Hospital

Hanoi, Hai Ba Trung, 100000, Vietnam

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Duong Dinh Toan, Ph.D

    Hanoi Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
365 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 26, 2024

Study Start

April 25, 2022

Primary Completion

June 30, 2023

Study Completion

December 1, 2023

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)