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Biochemical Approach to Measuring Surgical Trauma

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01037400
Collaborator
(none)
0
Enrollment
1
Location

Study Details

Study Description

Brief Summary

This study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. The sensitivity to injury will be characterized by the changes in mean serum concentration before and after surgery. Specificity for the injured state will be evaluated comparing the baseline to peak change (injury response) with the pre-surgery to follow-up baseline fluctuation (i.e. measurement noise).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues
    Study Start Date :
    Feb 1, 2010
    Anticipated Primary Completion Date :
    Feb 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Total Knee Replacement Patients

    Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis.

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and Specificity of biomarkers in response to tissue injury [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    • Age 18 to 75

    • No musculoskeletal injury requiring medical attention in the past 3 months other than entirely related to worsening symptoms of the operative knee or spinal level.

    • No musculoskeletal injury producing pain in the previous 2 weeks.

    • No inflammatory disease other than osteoarthritis)

    • No exercise with weights in the 2 weeks before surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph's Healthcare Hamilton Ontario Canada L8N4A6

    Sponsors and Collaborators

    • Hamilton Health Sciences Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anthony Adili, Associate Professor, McMaster University
    ClinicalTrials.gov Identifier:
    NCT01037400
    Other Study ID Numbers:
    • TKR Study
    First Posted:
    Dec 23, 2009
    Last Update Posted:
    Sep 17, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Anthony Adili, Associate Professor, McMaster University
    Knee Replacement
    Arthroplasty

    Study Results

    No Results Posted as of Sep 17, 2014