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NCT01037400 Clinical Trial

Biochemical Approach to Measuring Surgical Trauma

Total Knee Replacement Clinical Trial

Official title:
Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01037400
Other study ID # TKR Study
Secondary ID
Status Withdrawn
Phase N/A
First received December 22, 2009
Last updated September 16, 2014
Start date February 2010

Study information
Verified date September 2014
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of biomarkers in response to tissue injury 7 days No
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