Prediction of Outcomes Following Total Knee Replacement

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT01370421
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-10
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-13
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	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)	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States