Evaluation of Patellar Dimension and Bristol Index in Asi... | NCT05112978

Studies
Evaluation of Patellar Dimension and Bristol Index in Asian Population

NCT05112978

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Nov 9, 2021Actual

Enrollment

101Actual

Phase

Not provided

Conditions

Patello Femoral Syndrome

Interventions

Countries

Indonesia

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

Nov 2021

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

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Jan 31, 2021Actual

First Submitted Date

Nov 2, 2021

First Submission Date that Met QC Criteria

Nov 8, 2021

First Posted Date

Nov 9, 2021Actual

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

Nov 8, 2021

Last Update Posted Date

Nov 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Restoration of patellar thickness is pivotal during a total knee arthroplasty (TKA). Several studies showed there are differences in the knee measurements between Asian and Western population. This study aims to evaluate the patellar dimension and Bristol Index of patellar width to thickness (BIPWiT) using magnetic resonance imaging (MRI) in Asian population.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic Test	MRI genu non contrast

Measure	Description	Time Frame
bristol index		1 day MRI examination

Measure	Description	Time Frame
patellar sizes		1 day MRI examination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

knee pain

Exclusion Criteria:

degenerative joint disease
patellofemoral pathology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

all patients came to clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pondok Indah Hospital		Jakarta			Indonesia

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
D046788	Patellofemoral Pain Syndrome

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided