Shoe Inserts for Treating Osteoarthritis of the Knee

This study has been completed.

First Received on March 12, 2002. Last Updated on December 20, 2007 History of Changes

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00032240

Purpose

This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be studied.

Condition	Intervention	Phase
Osteoarthritis, Knee	Device: Shoe Insert	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomized Trial of a Wedged Insole for Treatment of Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment:	90
Study Start Date:	February 2002
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Medial knee osteoarthritis
Pain
No foot problems
Lives in Boston, Massachusetts Metro area

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032240

Locations

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

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

Investigators

Principal Investigator:

David T. Felson, MD

Boston University

More Information

Publications:

Kerrigan DC, Lelas JL, Goggins J, Merriman GJ, Kaplan RJ, Felson DT. Effectiveness of a lateral-wedge insole on knee varus torque in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2002 Jul;83(7):889-93.

Goggins J, Baker K, Felson D. What WOMAC pain score should make a patient eligible for a trial in knee osteoarthritis? J Rheumatol. 2005 Mar;32(3):540-2.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baker K, Goggins J, Xie H, Szumowski K, LaValley M, Hunter DJ, Felson DT. A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis. Arthritis Rheum. 2007 Apr;56(4):1198-203.

ClinicalTrials.gov Identifier:	NCT00032240 History of Changes
Other Study ID Numbers:	P60 AR47785, NIAMS-076
Study First Received:	March 12, 2002
Last Updated:	December 20, 2007
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biomechanics

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012