Status:

COMPLETED

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

Lead Sponsor:

University of Iowa

Collaborating Sponsors:

Physiatric Association of Spine, Sports and Occupational Rehabilitation

Foundation for Physical Medicine and Rehabilitation

Conditions:

Medial Compartment Knee Osteoarthritis

Eligibility:

All Genders

45+ years

Phase:

PHASE2

PHASE3

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 lo...

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, ris...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

May 1 2006

Trial Type :

INTERVENTIONAL

End Date :

August 1 2006

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT00331110

Start Date

May 1 2006

End Date

August 1 2006

Last Update

January 3 2008

Active Locations (1)

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1

University of Iowa

Iowa City, Iowa, United States, 52242