Clinical trial NCT01370421: Prediction of Outcomes Following Total Knee Replacement
Official title: Prediction of Outcomes Following Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 248
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants for this study will be recruited via flyers posted in hospital clinics, on electronic announcement boards and various other media mediums. Potential subjects will be informed about the study purpose and procedures when they call, and interested subjects will then go through a telephone screening.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert R Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: