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Biochemical Approach to Measuring Surgical Trauma

This study has been withdrawn prior to enrollment.
(No patients recruited)
Sponsor:
Information provided by (Responsible Party):
Anthony Adili, McMaster University
ClinicalTrials.gov Identifier:
NCT01037400
First received: December 22, 2009
Last updated: September 16, 2014
Last verified: September 2014

December 22, 2009
September 16, 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 ] [ Designated as safety issue: No ]
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).

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.
 
Withdrawn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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01037400
TKR Study
No
Anthony Adili, McMaster University
Hamilton Health Sciences Corporation
Not Provided
Not Provided
McMaster University
September 2014

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