Biochemical Approach to Measuring Surgical Trauma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01037400
First received: December 22, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 22, 2009
December 22, 2009
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
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).

Not Provided
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
Not Provided
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.
 
Not yet recruiting
40
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.
Both
18 Years to 75 Years
Yes
Contact: Leslie McKnight 9055221155 ext 35874
Canada
 
NCT01037400
TKR Study
No
Dr. Anthony Adili, St. Joseph's Healthcare
Hamilton Health Sciences Corporation
Not Provided
Not Provided
McMaster University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP