Status:
WITHDRAWN
BION Treatment of Knee Osteoarthritis
Lead Sponsor:
University of Southern California
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Osteoarthritic changes in the knee are a common cause of pain that restricts the subject's ability to move and may lead to surgical intervention with total knee replacement. Quadriceps muscle strength...
Detailed Description
Knee Osteoarthritis is a common problem with people over the age of 50 and is often debilitating because of the challenges it poses to normal walking function. Research has shown that exercise can les...
Eligibility Criteria
Inclusion
- Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
- Subject is between 18 and 75 years old.
- Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
- Subject is mentally capable of understanding the goals and the application of therapy.
- Subject is able to apply the therapy (with or without help) in the home setting.
- Subject is willing and capable of giving informed consent.
- Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.
Exclusion
- Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
- Subject has a history of falling.
- Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
- Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
- Subject has cancer.
- Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
- Subject has bilateral knee osteoarthritis.
- Subject is taking pain medications with dosage not stable for one month.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00689286
Start Date
April 1 2008
End Date
December 1 2008
Last Update
June 3 2015
Active Locations (1)
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1
USC University Hospital
Los Angeles, California, United States, 90033