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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This study has been withdrawn prior to enrollment.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
  Purpose
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
Total Knee Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues

Resource links provided by NLM:


Further study details as provided by Anthony Adili, McMaster University:

Primary Outcome Measures:
  • Sensitivity and Specificity of biomarkers in response to tissue injury [ Time Frame: 7 days ]

Biospecimen Retention:   Samples With DNA
Plasma and Serum

Enrollment: 0
Study Start Date: February 2010
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037400


Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
  More Information

Responsible Party: Anthony Adili, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01037400     History of Changes
Other Study ID Numbers: TKR Study
First Submitted: December 22, 2009
First Posted: December 23, 2009
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Anthony Adili, McMaster University:
Knee Replacement
Arthroplasty