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
  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 McMaster University:

Primary Outcome Measures:
  • Sensitivity and Specificity of biomarkers in response to tissue injury [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma and Serum


Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037400

Contacts
Contact: Leslie McKnight 9055221155 ext 35874

Locations
Canada, Ontario
St. Joseph's Healthcare Not yet recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Leslie McKnight    9055221155 ext 35874      
Principal Investigator: Anthony Adili, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Dr. Anthony Adili, St. Joseph's Healthcare
ClinicalTrials.gov Identifier: NCT01037400     History of Changes
Other Study ID Numbers: TKR Study
Study First Received: December 22, 2009
Last Updated: December 22, 2009
Health Authority: Canada: St. Joseph's Healthcare Hamilton Research Ethics Board

Keywords provided by McMaster University:
Knee Replacement
Arthroplasty

ClinicalTrials.gov processed this record on July 20, 2014