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Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neutral insole with subtalar strapping (sham)
Lateral wedge insole with subtalar strapping
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, osteoarthritis, knee, foot orthoses, orthotic insoles

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto de Ortopedia e Traumatologia HC-FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Wedge

Neutral

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ankle pain
Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability

Full Information

First Posted
November 22, 2012
Last Updated
September 10, 2013
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01739296
Brief Title
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis
Official Title
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, osteoarthritis, knee, foot orthoses, orthotic insoles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wedge
Arm Type
Experimental
Arm Description
Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily
Arm Title
Neutral
Arm Type
Sham Comparator
Arm Description
Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily
Intervention Type
Other
Intervention Name(s)
Neutral insole with subtalar strapping (sham)
Other Intervention Name(s)
Neutral
Intervention Description
Neutral insole with subtalar strapping (sham)
Intervention Type
Other
Intervention Name(s)
Lateral wedge insole with subtalar strapping
Other Intervention Name(s)
Wedge
Intervention Description
Lateral wedge insole with subtalar strapping
Primary Outcome Measure Information:
Title
Symptoms
Description
Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Ankle pain
Description
Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability
Time Frame
24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo C Campos, MD
Organizational Affiliation
FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ortopedia e Traumatologia HC-FMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05410-000
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://sbot.org.br
Description
Brazilian Orthopaedics Association
URL
http://iothcfmusp.com.br
Description
Orthopaedics and Traumatology Institute website
URL
http://fmusp.org.br
Description
University of São Paulo website
URL
http://sbcj.org.br
Description
Brazilian Knee Surgery Association website

Learn more about this trial

Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

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