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Wedged Orthoses and Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420147
First Posted: January 9, 2007
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Todd D. Royer, University of Delaware
  Purpose
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.

Condition Intervention
Knee Osteoarthritis Device: wedged inshoe orthosis Device: neutral inshoe orthosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of In-shoe Wedges on Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Todd D. Royer, University of Delaware:

Primary Outcome Measures:
  • Knee Adduction Moment at Baseline [ Time Frame: Baseline ]
  • Knee Adduction Moment After 12 Months [ Time Frame: 12 months ]

Enrollment: 38
Study Start Date: February 2002
Study Completion Date: November 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wedged Orthosis
Subjects were given a wedged inshoe orthosis
Device: wedged inshoe orthosis
Treatment subjects were prescribed an inshoe wedged orthosis
Placebo Comparator: Neutral Orthosis
Subjects were given a neutral inshoe orthosis.
Device: neutral inshoe orthosis
Control subjects were prescribed a neutral inshoe 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.
  Eligibility

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420147


Locations
United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
University of Delaware
Investigators
Principal Investigator: Todd Royer, PhD University of Delaware
  More Information

Responsible Party: Todd D. Royer, Associate Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT00420147     History of Changes
Other Study ID Numbers: P20RR16458-3
First Submitted: January 5, 2007
First Posted: January 9, 2007
Results First Submitted: December 19, 2013
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Todd D. Royer, University of Delaware:
knee osteoarthritis
orthosis
wedge
gait

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases