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Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

NCT ID: NCT01739296

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Keywords

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osteoarthritis osteoarthritis, knee foot orthoses orthotic insoles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Wedge

Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily

Group Type EXPERIMENTAL

Lateral wedge insole with subtalar strapping

Intervention Type OTHER

Lateral wedge insole with subtalar strapping

Neutral

Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily

Group Type SHAM_COMPARATOR

Neutral insole with subtalar strapping (sham)

Intervention Type OTHER

Neutral insole with subtalar strapping (sham)

Interventions

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Neutral insole with subtalar strapping (sham)

Neutral insole with subtalar strapping (sham)

Intervention Type OTHER

Lateral wedge insole with subtalar strapping

Lateral wedge insole with subtalar strapping

Intervention Type OTHER

Other Intervention Names

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Neutral Wedge

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustavo C Campos, MD

Role: PRINCIPAL_INVESTIGATOR

FMUSP

Locations

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Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://sbot.org.br

Brazilian Orthopaedics Association

http://iothcfmusp.com.br

Orthopaedics and Traumatology Institute website

http://fmusp.org.br

University of São Paulo website

http://sbcj.org.br

Brazilian Knee Surgery Association website

Other Identifiers

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839/2011

Identifier Type: -

Identifier Source: org_study_id