Status:
COMPLETED
A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Osteoarthritis
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of ...
Detailed Description
Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints. Knee OA causes substantial pain, suffering, and disa...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Able and willing to give informed consent and to comply with the study protocol and follow-up instructions
- Symptomatic and radiographic OA of the knee
- Knee pain upon walking
- Predominant medial compartment OA
- Exclusion Criteria
- Knee flexion contracture of greater than 15 degrees or inability to walk without assistance
- Predominant lateral compartment OA of either knee
- Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
- Clinically evident OA of the ankle or hip
- Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
- Substantial obesity, defined as having body mass index (BMI) greater than 35
- Anticipation of surgery involving any joint of either lower extremity in the next 3 years
- Habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
- Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
- Chronic infection in any joint of the lower extremities
- History of fracture of either lower extremity within 6 months of study entry
- History of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
- History of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
- Pregnancy
- Any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00076453
Start Date
June 1 2003
End Date
December 1 2007
Last Update
September 27 2011
Active Locations (1)
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1
Rush University Medical Center, Section of Rheumatology
Chicago, Illinois, United States, 60612