Prediction of Outcomes Following Total Knee Replacement (POKR)

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Mass General Brigham

Status

Completed

Conditions

Osteoarthritis

Study type

Observational

Funder types

Other

Identifiers

NCT01370421
2010p000978

Details and patient eligibility

About

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.

Full 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.

Enrollment

248 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

248 participants in 1 patient group

Knee OA patients undergoing Total Knee Arthroplasty (TKA)
Description:
Participants will be 45 years or older, diagnosed with Osteoarthritis of the knee and be scheduled for a unilateral total knee replacement surgery.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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