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

NCT ID: NCT00331110

Last Updated: 2008-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2006-08-31

Brief Summary

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).

Detailed Description

Osteoarthritis (OA) of the knee is a common cause of pain and disability and the medial compartment is involved most frequently. If conservative mechanical therapies could reduce knee OA symptoms, risks to patients might be minimized through reduction in use of pharmacotherapy or surgery. A lateral heel wedge with strapping of the ankle joint has been reported to induce a similar therapeutic effect to that of proximal tibial osteotomy. It is presumed that the mechanism for this involves correction of genu varum. However, the effects on the static lower limb mechanical axis and the dynamic knee adduction moment, a risk factor for knee OA symptoms and progression, have not been assessed, so the mechanism of effect is currently unknown. The proposed protocol would compare lower limb mechanical alignment (measured by radiographic hip-knee-ankle angle) and dynamic knee varus moment (measured by 3-dimensional gait analysis) with and without the strapped insole to further understanding of the mechanism of effect on subjects with knee OA. Additionally, this protocol would assess analgesia and whether use of the insole reduces known knee joint unloading compensatory mechanisms during gait. Through measurement of radiographic lower limb alignment, dynamic knee varus moment, and ankle/foot static and dynamic angles, a model would be developed relating radiographs with dynamic moments, potentially allowing greater risk stratification for knee OA development and progression through use of radiographs. In addition to elucidating the mechanism of effect of this insole and developing a model for radiographic interpretation, this protocol would be the fist study of this insole involving non-Japanese subjects.

Conditions

Medial Compartment Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Laterally-Wedged Insole with Ankle Strapping

Intervention Type: DEVICE

Laterally-Weged Insole

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physiatric Association of Spine, Sports and Occupational Rehabilitation

OTHER

Sponsor Role: collaborator

Foundation for Physical Medicine and Rehabilitation

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Principal Investigators

Neil A Segal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

200501707

Identifier Type: -

Identifier Source: org_study_id