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Biochemical Approach to Measuring Surgical Trauma

This study has been withdrawn prior to enrollment.
(No patients recruited)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037400
First Posted: December 23, 2009
Last Update Posted: September 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthony Adili, McMaster University
December 22, 2009
December 23, 2009
September 17, 2014
February 2010
February 2011   (Final data collection date for primary outcome measure)
Sensitivity and Specificity of biomarkers in response to tissue injury [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT01037400 on ClinicalTrials.gov Archive Site
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Biochemical Approach to Measuring Surgical Trauma
Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues
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).
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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Plasma and Serum
Non-Probability Sample
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.
Total Knee Replacement
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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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01037400
TKR Study
No
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Anthony Adili, McMaster University
Hamilton Health Sciences Corporation
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Not Provided
McMaster University
September 2014