Shoe Inserts for Treating Osteoarthritis of the Knee - Tabular View

Tracking Information

First Received Date ^ICMJE

March 12, 2002

Last Updated Date

December 20, 2007

Start Date ^ICMJE

February 2002

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00032240 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Shoe Inserts for Treating Osteoarthritis of the Knee

Official Title ^ICMJE

Randomized Trial of a Wedged Insole for Treatment of Osteoarthritis of the Knee

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Device: Shoe Insert

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

45 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00032240

Responsible Party

Study ID Numbers ^ICMJE

P60 AR47785, NIAMS-076

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David T. Felson, MD

Boston University

Information Provided By

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

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP