Prediction of Outcomes Following Total Knee Replacement

Study Overview
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Brief Summary
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This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Detailed Description
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This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. The last visit will be about 1 year after surgery. You may be eligible if you are 50 or older, will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Official Title
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Prediction of Outcomes Following Total Knee Replacement

Conditions
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Osteoarthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 or older Meet the American College of Rheumatology criteria for knee osteoarthritis Scheduled to undergo total knee arthroplasty Facility with the English language that is adequate to complete study procedures Exclusion Criteria: Cognitive impairment preventing completion of study assessment procedures Myocardial infarction within the past 12 months Severe raynaud's or severe neuropathy Active vasculitis or severe peripheral vascular disease Current infection Use of oral steroids Recent history of substance abuse or dependence Confirmed diagnosis of periodic limb movement disorder or restless legs syndrome Systemic inflammatory or autoimmune disorders such as rheumatoid arthritis, lupus, etc. Known anemia

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee OA patients undergoing Total Knee Arthroplasty (TKA)<br>Participants will be 45 years or older, diagnosed with Osteoarthritis of the knee and be scheduled for a unilateral total knee replacement surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) | A widely-used measure of pain severity and pain interference. Pain severity and pain interference scores range from 0-10 (0= no pain / no pain interference and 10= severe pain / pain interference). | 6 months | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | A widely-used, OA-specific measure of pain, function, and stiffness. WOMAC Pain scores range from 0-50, with 0= no pain and 50= severe pain. | 6 months |