Application of Knee Measurements on 3D CT in TKR | NCT06475014

Studies
Application of Knee Measurements on 3D CT in TKR

NCT06475014

Sponsor

Vinmec Healthcare System

Status

Completed

Last Update Posted

Jun 26, 2024Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Knee Osteoarthritis
Knee Disease

Interventions

Total knee replacement

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2022Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Jun 13, 2024

First Submission Date that Met QC Criteria

Jun 19, 2024

First Posted Date

Jun 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2024

Last Update Posted Date

Jun 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A 3D Computed Tomographic Study of Vietnamese Knee Morphology for 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

365 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knee with OA		Underwent Total Knee replacement Surgery, using 3D printed PSI,	Procedure: Total knee replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total knee replacement	Procedure	Mechanical Alignment Using PSI Pre and post-operative CT Scan	Knee with OA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Participants with severe osteoarthritis of the knee who underwent primary TKA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Duong Dinh Toan, Ph.D	Hanoi Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vinmec Times City Hospital		Hanoi	Hai Ba Trung	100000	Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided