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NCT01739296 Clinical Trial

Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01739296
Other study ID # 839/2011
Secondary ID
Status Completed
Phase N/A
First received November 22, 2012
Last updated September 10, 2013
Start date June 2011
Est. completion date July 2012

Study information
Verified date September 2013
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date July 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Neutral insole with subtalar strapping (sham)
Neutral insole with subtalar strapping (sham)
• Lateral wedge insole with subtalar strapping
Lateral wedge insole with subtalar strapping

Locations
Country Name City State
Brazil Instituto de Ortopedia e Traumatologia HC-FMUSP São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Ankle pain Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability 24 weeks Yes
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