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Shoe Inserts for Treating Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Shoe Insert

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Biomechanics

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Boston University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00032240

First Posted

March 12, 2002

Last Updated

June 2, 2013

Sponsor

Boston University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00032240

Brief Title

Shoe Inserts for Treating Osteoarthritis of the Knee

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

February 2002 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boston University

Collaborators

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

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Biomechanics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Shoe Insert

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David T. Felson, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12098144

Citation

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. doi: 10.1053/apmr.2002.33225.

Results Reference

background

PubMed Identifier

15742450

Citation

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.

Results Reference

background

PubMed Identifier

17393448

Citation

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. doi: 10.1002/art.22516.

Results Reference

derived

Learn more about this trial

Shoe Inserts for Treating Osteoarthritis of the Knee

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