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Wedged Orthoses and Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
wedged inshoe orthosis
neutral inshoe orthosis
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, orthosis, wedge, gait

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wedged Orthosis

Neutral Orthosis

Arm Description

Subjects were given a wedged inshoe orthosis

Subjects were given a neutral inshoe orthosis.

Outcomes

Primary Outcome Measures

Knee Adduction Moment at Baseline
Knee Adduction Moment After 12 Months

Secondary Outcome Measures

Full Information

First Posted
January 5, 2007
Last Updated
April 3, 2017
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT00420147
Brief Title
Wedged Orthoses and Knee Osteoarthritis
Official Title
Effect of In-shoe Wedges on Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, orthosis, wedge, gait

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Wedged Orthosis
Arm Type
Experimental
Arm Description
Subjects were given a wedged inshoe orthosis
Arm Title
Neutral Orthosis
Arm Type
Placebo Comparator
Arm Description
Subjects were given a neutral inshoe orthosis.
Intervention Type
Device
Intervention Name(s)
wedged inshoe orthosis
Intervention Description
Treatment subjects were prescribed an inshoe wedged orthosis
Intervention Type
Device
Intervention Name(s)
neutral inshoe orthosis
Intervention Description
Control subjects were prescribed a neutral inshoe orthosis
Primary Outcome Measure Information:
Title
Knee Adduction Moment at Baseline
Time Frame
Baseline
Title
Knee Adduction Moment After 12 Months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Royer, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Wedged Orthoses and Knee Osteoarthritis

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