N/A
N=38
Wedged Orthoses and Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00420147 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Knee Adduction Moment at Baseline — 0.376; 0.342 Nm/(kg-m)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- wedged inshoe orthosis (Device); neutral inshoe orthosis (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Adduction Moment at Baseline |
0.376; 0.342 | — |
| PRIMARY Knee Adduction Moment After 12 Months |
0.408; 0.358 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00420147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.