Osteoarthritis Clinical Study Information


The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease.

 

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The following is a listing of all of the evaluation tools that will be used in this study, for test and placebo subjects alike.

  • The American College of Rheumatology (ACR) Classification Criteria for Osteoarthritis of the Hip Reference: R. Altman, G. Alarcon, D. Appelrouth, D. Bloch, D. Borenstein, K. Brandt, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum 1991;34:505--514.

The American College of Rheumatology (ACR) has developed classification criteria for classification and reporting of osteoarthritis involving the hip that is the most widely recognized and used criteria for the classification and reporting of osteoarthritis of the hip.

This classification method yields a sensitivity of 86% and a specificity of 75%.

The ACR classification criteria for osteoarthritis of the hip is as follows:

  1. Hip pain
  2. AND AT LEAST TWO OF THE THREE FOLLOWING FEATURES:
  3. Erythrocyte sedimentation rate (ESR) less than 20 mm/hour;
  4. Radiographic femoral or acetabular osteophytes;
  5. Radiographic joint space narrowing (superior, axial, and/or medial).

Because the presence of osteophytes on x-ray is a protocol required inclusion criteria (defined by a Kellgren-Lawrence x-ray Grade of >=2), the protocol defined requirement for diagnosis of osteoarthritis of the hip will be the presence of hip pain (1), presence of osteophytes on x-ray (3) and either an ESR < 20 mm/hour (2) OR joint space narrowing on x-ray (4).

 


 
 

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