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OpenTrials
Completed

NCT Number: NCT01370421

Prediction of Outcomes Following Total Knee Replacement

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: POKR

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2011
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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