Prediction of Outcomes Following Total Knee Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Brief Pain Inventory (BPI)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Brief Pain Inventory (BPI)
Time Frame: 6 months
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).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 6 months
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Robert Edwards
Principal Investigator
Brigham and Women's Hospital