One-Leg Standing Radiograph: A Novel Technique to Evaluat... | NCT02051699

Studies
One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of OA Knee

NCT02051699

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Jan 31, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Severity of OA Knee
Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph

Interventions

radiographic of standing knee

Countries

Thailand

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

Jan 2014

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

Jun 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jan 30, 2014

First Submission Date that Met QC Criteria

Jan 30, 2014

First Posted Date

Jan 31, 2014Estimated

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

Jan 30, 2014

Last Update Posted Date

Jan 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee

Detailed Description

All patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. Medial and lateral joint space width were measured. The severity of OA knee was identified by the Kellgren-Lawrence (KL) classification.

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

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One-leg standing view			Procedure: radiographic of standing knee
both-leg standing view			Procedure: radiographic of standing knee

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiographic of standing knee	Procedure	the patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee	One-leg standing view

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of joint space with between one-leg standing and both-leg standing radiographs in OA knee patients		one day

Secondary Outcomes

Measure	Description	Time Frame
Change of radiographic grading between one-leg and both-leg standing AP views in OA knee patients		one day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral knee pain more than 3 months

Exclusion Criteria:

Inflammatory OA knee
previous knee injury
previous knee infection
previous knee surgery
pregnant women
unable to bear weight on one leg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

the patients who came to our clinic which bilateral knee pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
supakit kanitnate, M.D.	orthopaedic department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
department of orthopaedic surgery, Faculty of medicine, Thammasat university		Khlong Luang	Changwat Pathum Thani	066	Thailand

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