Wedged Orthoses and Knee Osteoarthritis

• ClinicalTrials.gov Identifier: NCT00420147
• Recruitment Status: Completed
• First Posted: January 9, 2007
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Sponsor: University of Delaware
• Information provided by (Responsible Party): Todd D. Royer, University of Delaware

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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Device: wedged inshoe orthosis; Device: neutral inshoe orthosis	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of In-shoe Wedges on Knee Osteoarthritis
• Study Start Date: February 2002
• Actual Primary Completion Date: February 2006
• Actual Study Completion Date: November 2007

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Knee Adduction Moment at Baseline [ Time Frame: Baseline ]
2. Knee Adduction Moment After 12 Months [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: P20RR16458-3
• First Posted: January 9, 2007
• 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