Lateral Wedge Insole With Subtalar Strapping for Knee Ost... | NCT01739296

Studies
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

NCT01739296

Sponsor

University of Sao Paulo General Hospital

Status

Completed

Last Update Posted

Sep 11, 2013Estimated

Enrollment

58Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Neutral insole with subtalar strapping (sham)
Lateral wedge insole with subtalar strapping

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

Sep 2013

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 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 22, 2012

First Submission Date that Met QC Criteria

Nov 30, 2012

First Posted Date

Dec 3, 2012Estimated

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

Sep 10, 2013

Last Update Posted Date

Sep 11, 2013Estimated

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

This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

Detailed Description

The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

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

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Wedge	Experimental	Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily	Other: Lateral wedge insole with subtalar strapping
Neutral	Sham Comparator	Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily	Other: Neutral insole with subtalar strapping (sham)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neutral insole with subtalar strapping (sham)	Other	Neutral insole with subtalar strapping (sham)	Neutral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms	Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Ankle pain	Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability	24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the American College of Rheumatology criteria for knee Osteoarthritis
Varus malalignment of the knee
Absence of previous fracture on the index knee
Absence of previous surgery on the index knee
Absence of Rheumatoid Arthritis
No Intra-articular injection on the index knee in the past 6 months
Receiving usual care for Osteoarthritis for at least 6 months
Be able to understand and agree with the informed consent

Exclusion Criteria:

Undergo surgery during the study
Undergo Intra-articular injection during the study
Develop articular infection of the index joint during the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gustavo C Campos, MD	FMUSP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Ortopedia e Traumatologia HC-FMUSP		São Paulo	São Paulo	05410-000	Brazil

References Module

Citations

Not provided

Label	URL
Brazilian Orthopaedics Association	View source
Orthopaedics and Traumatology Institute website	View source
University of São Paulo website

ID	Term
D010003	Osteoarthritis
D020370	Osteoarthritis, Knee

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases