A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
Completed · Not applicable
Conditions studied: Osteoarthritis
In brief
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 knee osteoarthritis.
Key facts
- Study ID
- NCT00076453
- Run by
- Rush University Medical Center
- People needed
- 100
- Starts
- 2003-06-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2011-09-27
Who can join
Age: 25 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rush University Medical Center, Section of Rheumatology — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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