Shoe Inserts for Treating Osteoarthritis of the Knee

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00032240
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 90
• Location: 1
• Duration (Months): 53.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Device: Shoe Insert	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Randomized Trial of a Wedged Insole for Treatment of Osteoarthritis of the Knee
• Study Start Date: Feb 1, 2002
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Medial knee osteoarthritis

• Pain

• No foot problems

• Lives in Boston, Massachusetts Metro area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston University
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Principal Investigator: David T. Felson, MD, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00032240
• Other Study ID Numbers: P60AR047785; P60AR047785; NIAMS-076
• First Posted: Mar 13, 2002
• Last Update Posted: Jun 4, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by , ,: Biomechanics
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 4, 2013