Completed

Clinical Effects of Altered Biomechanics in Knee Osteoarthritis

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What is being tested

Lateral wedge orthotic shoe inserts

+ Standard orthotic shoe inserts

Device
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

Over 25 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorRush University Medical Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2003

Actual date on which the first participant was enrolled.

Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints. Knee OA causes substantial pain, suffering, and disability, as well as enormous economic burden on the patient; unfortunately, treatment provides relief but not a cure. The majority of patients with symptomatic knee OA do not attain satisfactory long-term relief, even with recent advances in pain relievers. Analgesic treatment may relieve the pain but does not improve biomechanics and may even aggravate OA. Although OA is complex and not completely understood, disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading. Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration; one such device is a lateral wedge orthotic shoe insert. When worn during weight-bearing activity, these inserts have been shown to reduce loading of the medial compartment and may provide pain relief. This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA. The study will also assess improvements in loading biomechanics of the knee. This is a 3-year study. Patients will be randomly assigned to one of two groups; the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts. There will be 10 study visits during the course of the study. Patients will undergo X-rays and bone mineral density testing (DEXA) and 3 blood collections during the course of the study.

Official TitleClinical Effects of Altered Biomechanics in Knee Osteoarthritis 
NCT00076453
Principal SponsorRush University Medical Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic Diseases

Criteria

Inclusion Criteria * Able and willing to give informed consent and to comply with the study protocol and follow-up instructions * Symptomatic and radiographic OA of the knee * Knee pain upon walking * Predominant medial compartment OA Exclusion Criteria * Knee flexion contracture of greater than 15 degrees or inability to walk without assistance * Predominant lateral compartment OA of either knee * Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis * Clinically evident OA of the ankle or hip * Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics * Substantial obesity, defined as having body mass index (BMI) greater than 35 * Anticipation of surgery involving any joint of either lower extremity in the next 3 years * Habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts * Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout * Chronic infection in any joint of the lower extremities * History of fracture of either lower extremity within 6 months of study entry * History of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry * History of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry * Pregnancy * Any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will wear lateral wedge orthotic inserts.

Group II

Active Comparator
Participants will wear standard orthotic inserts.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Rush University Medical Center, Section of Rheumatology

Chicago, United StatesSee the location
CompletedOne Study Center