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Completed

NCT Number: NCT01739296

Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, 05410-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neutral insole with subtalar strapping (sham)

Other

Neutral insole with subtalar strapping (sham)

Other names: Neutral

Lateral wedge insole with subtalar strapping

Other

Lateral wedge insole with subtalar strapping

Other names: Wedge

Primary outcomes

  1. Symptoms

    Time frame: 24 weeks

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

Secondary outcomes

  1. Ankle pain

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2012
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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