Anterior Wedge in Patients With Osteoarthritis Hip | NCT03393923

Studies
Anterior Wedge in Patients With Osteoarthritis Hip

NCT03393923

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Status

Completed

Last Update Posted

Feb 26, 2019Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Gait, Frontal

Interventions

Application of the anterior wedge

Countries

Brazil

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 2017

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

Jul 10, 2017Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Dec 10, 2018Actual

First Submitted Date

Jan 3, 2018

First Submission Date that Met QC Criteria

Jan 3, 2018

First Posted Date

Jan 9, 2018Actual

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

Feb 25, 2019

Last Update Posted Date

Feb 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudio Cazarini Junior, Claudio Cazarini Júnior, Faculdade de Ciências Médicas da Santa Casa de São PauloPrincipal Investigator

Lead Sponsor

Faculdade de Ciências Médicas da Santa Casa de São PauloOTHER

Collaborators

Not provided

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

Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major disability and poor quality of life. Understand the musculoskeletal factores can lead to a better clinical management. The muscle strenghening of posterolateral complexo of hip is a important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze of gait through of Myovídeo analysis software.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention	Patient will undergo gait analysis
Experimental group	Experimental	Patient will undergo gait analysis with use of anterior wedge	Other: Application of the anterior wedge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Application of the anterior wedge	Other	Application of anterior wedge in tennis	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inproved performance of the gluteus maximus	Extent moment will be assessed by gait analysis	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sedentary individuals
Both genders
Age equal to or greather than 50 years
Diagnosis of osteoarthritis level II and III

Exclusion Criteria:

fractures
Neuromuscular diseases
Other diseases of hip

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Flávia Nakatake		São Paulo		03918000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020233	Gait Disorders, Neurologic

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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