A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain

September 26, 2011 updated by: Rush University Medical Center

Clinical Effects of Altered Biomechanics in Knee Osteoarthritis

Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center, Section of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will wear lateral wedge orthotic inserts.
Device: Lateral wedge orthotic shoe inserts
Customized lateral wedge orthotic shoe inserts
Active Comparator: 2
Participants will wear standard orthotic inserts.
Device: Standard orthotic shoe inserts
Neutral orthotic inserts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction
Time Frame: Years 2 and 3
Years 2 and 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in loading of the medial knee
Time Frame: Years 2 and 3
Years 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Joel A. Block, MD, Rush University Medical Center, Section of Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 22, 2004

First Submitted That Met QC Criteria

January 23, 2004

First Posted (Estimate)

January 26, 2004

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAMS-116
  • 2P50AR039239-16 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Lateral wedge orthotic shoe inserts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe