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OpenTrials
Completed

NCT Number: NCT00420147

Wedged Orthoses and Knee Osteoarthritis

The five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on lower extremity function in patients with knee osteoarthritis. In general, our aims address the long-term effects of orthoses. The investigators hypothesize that subjects who use the lateral wedged in shoe orthosis will result in altered gait mechanics that reflect a reduction in the frontal plane knee joint moment compared to subjects who use a neutral in shoe orthosis.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

Introduction: In shoe wedged orthoses have been shown to be an effective conservative approach in reducing pain in patients with osteoarthritis (OA). The mechanism responsible for this pain reduction is not well-understood. It is not known whether placing a medial or lateral wedge in the shoe results in alterations in lower extremity alignment, knee joint moments or some combination of the two. The longterm effects of this intervention on OA patients' functional status as well the progression of their OA has not been studied. Therefore, the purpose of this study is to examine the effect of in-shoe wedged orthoses in patients with knee OA on the frontal plane knee joint moment. Methods: 38 patients between the ages of 40-70 yrs with knee OA (grades I-IV) will be recruited from within the medical community. Subjects with a diagnosis of unilateral knee OA of greater than 3 months duration, as defined by the American College of Rheumatology Guidelines, will be included. 19 subjects will be assigned to a treatment group and 19 subjects will be assigned to a control group. The treatment group will receive custom molded orthotics with a lateral wedge. Both the treatment and control groups will be tested initially and then again 1 year later. The dependent variable is peak knee adduction moment. Statistics: A two-way ANOVA will be used to test the hypothesis. This design will include 2 levels of group (control and treatment) and two levels of trial (pretest and 1 yr posttest). Significance will be determined at a level of p<.05.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed unilateral knee osteoarthritis by a qualified physician
  • Recent (within 3 months of entrance into the study) radiographic confirmation of OA grade (I-IV) as evidenced by joint space narrowing and the presence of osteophytes
  • A score of 50-90 mm on a 100 mm visual analogue pain scale for walking
  • Ability to walk independently without the use of assistive devices

Exclusion criteria

  • History of lower extremity joint surgery or other lower extremity injury that would hinder ambulation
  • Severe foot deformity that would prevent the accommodation of the wedged orthotic device
  • Other disease process such as neurologic, cardiac, or oncologic, that would hinder one's ability to ambulate
  • Any condition, such as diabetes, that results in loss of sensation in the lower extremities

Treatment and study plan

wedged inshoe orthosis

Device

Treatment subjects were prescribed an inshoe wedged orthosis

neutral inshoe orthosis

Device

Control subjects were prescribed a neutral inshoe orthosis

Primary outcomes

  1. Knee Adduction Moment at Baseline

    Time frame: Baseline

  2. Knee Adduction Moment After 12 Months

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Effect of In-shoe Wedges on Knee Osteoarthritis

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Jan 9, 2007
Registry last updated
Jun 16, 2017

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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