Clincosm LogoSign in Get a demo

POKR: Prediction of Outcomes Following Total Knee Replacement

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01370421
Collaborator
(none)
248
Enrollment
1
Location
95
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Actual Enrollment :
    248 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Outcomes Following Total Knee Replacement
    Actual Study Start Date :
    Apr 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2019
    Actual Study Completion Date :
    Mar 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Knee OA patients undergoing Total Knee Arthroplasty (TKA)

    Participants will be 45 years or older, diagnosed with Osteoarthritis of the knee and be scheduled for a unilateral total knee replacement surgery.

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Chestnut Hill Massachusetts United States 02467

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Robert R Edwards, PhD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Edwards, Principal Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT01370421
    Other Study ID Numbers:
    • 2010p000978
    First Posted:
    Jun 10, 2011
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Mar 2, 2022