Wedged Orthoses and Knee Osteoarthritis

NCT00420147 | Completed Results

• 2 other identifiers: P20RR16458-3P20RR016458
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; orthosis; wedge; gait

Outcome Measures

Primary Outcomes (2)

• Knee Adduction Moment at Baseline

  Baseline

• Knee Adduction Moment After 12 Months

  12 months

Study Arms (2)

Wedged Orthosis

EXPERIMENTAL

Subjects were given a wedged inshoe orthosis

Device: wedged inshoe orthosis

Neutral Orthosis

PLACEBO COMPARATOR

Subjects were given a neutral inshoe orthosis.

Device: neutral inshoe orthosis

Interventions

wedged inshoe orthosis DEVICE

Treatment subjects were prescribed an inshoe wedged orthosis

Wedged Orthosis

neutral inshoe orthosis DEVICE

Control subjects were prescribed a neutral inshoe orthosis

Neutral Orthosis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Compliance with the wedged orthoses was self reported by the subjects. There was difficulty with the larger degrees of wedging (10-15 degrees) fitting into the footwear.

Results Point of Contact

• Title: Todd Royer
• Organization: University of Delaware

royer@udel.edu

302-831-4351

Study Officials

• Todd Royer, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 9, 2007
• Study Start: February 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: November 1, 2007
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)