Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, orthosis, wedge, gait
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.
Interventions
DEVICEwedged inshoe orthosis
Treatment subjects were prescribed an inshoe wedged orthosis
DEVICEneutral inshoe orthosis
Control subjects were prescribed a neutral inshoe orthosis
Sponsors
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Adduction Moment at Baseline | Baseline |
| Knee Adduction Moment After 12 Months | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medial Knee OA - Control These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a neutral (non-wedged) in-shoe orthosis as their treatment. | 19 |
| Medial Knee OA - Treatment These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a wedged in-shoe orthosis as their treatment. | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Medial Knee OA - Treatment | Medial Knee OA - Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Continuous | 62.0 years STANDARD_DEVIATION 7.4 | 62.8 years STANDARD_DEVIATION 9.6 | 62.4 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Knee Adduction Moment After 12 Months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Knee OA - Control | Knee Adduction Moment After 12 Months | 0.408 Nm/(kg-m) | Standard Deviation 0.108 |
| Medial Knee OA - Treatment | Knee Adduction Moment After 12 Months | 0.358 Nm/(kg-m) | Standard Deviation 0.127 |
Primary
Knee Adduction Moment at Baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medial Knee OA - Control | Knee Adduction Moment at Baseline | 0.376 Nm/(kg-m) | Standard Deviation 0.118 |
| Medial Knee OA - Treatment | Knee Adduction Moment at Baseline | 0.342 Nm/(kg-m) | Standard Deviation 0.131 |