Shoe Inserts for Treating Osteoarthritis of the Knee

NCT ID: NCT00032240

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2006-08-31

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Shoe Insert

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Medial knee osteoarthritis
* Pain
* No foot problems
* Lives in Boston, Massachusetts Metro area
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Principal Investigators

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David T. Felson, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12098144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15742450 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17393448 (View on PubMed)

Other Identifiers

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P60AR047785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-076

Identifier Type: -

Identifier Source: secondary_id

P60AR047785

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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