Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis

Completed · Phase 2/Phase 3

Conditions studied: Medial Compartment Knee Osteoarthritis

In brief

The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design, the following aims and hypotheses will be addressed: Biomechanical Hypotheses 1. Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle towards 180° or talar valgus angulation. 2. Use of the insole with ankle strapping significantly reduces peak knee external varus moment during gait. 3. Use of the insole with ankle strapping significantly reduces foot external rotation (out-toeing) or widened base during gait analysis. 4. The radiographic HKA angle and tilt angle of the talus will predict knee peak external varus moment during gait. Clinical Hypotheses 1\. The use of an insole with ankle strapping over a two-week period will reduce knee pain (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).

Key facts

Study ID

NCT00331110

Run by

University of Iowa

People needed

14

Starts

2006-05-01

Expected to finish

2006-08-01

Last updated by the study team

2008-01-03

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects aged 45 or over will be included if they have predominantly medial compartment knee OA by American College of Rheumatology criteria, with medial knee pain rated at least 40/100mm on a visual analogue scale on most days of the month during one of the past 3 months.

You may not qualify if…

• Potential subjects with a body mass index (BMI) of greater than 35 will be excluded to avoid the potential confounding effect of increased weight on the height of the insole. Other exclusion criteria will include: known injury or surgery involving bone or cartilage of the knee or ankle which may alter gait, history of factors which might alter response to use of a laterally wedged insole (e.g. greater or similar reduction in lateral compared with medial femorotibial jont space width on posterior-anterior radiographs, tibial osteotomy, congenital foot problems, fused joints, foot deformity, known limitation of range of motion of the subtalar joint), known neuromuscular disease, co-morbid disease which might confound gait analysis (e.g. hip OA, ankle OA, hallux rigidus, valgus deformity of the midfoot, other symptomatic deformity of the foot, advanced arthroplasty of the hindfoot, previous ankle arthrodesis, unable to walk without a gait aid), current use of an orthotic insole, inability to comply with study protocol.

Where it is running

• University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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