Biochemical Approach to Measuring Surgical Trauma

NCT ID: NCT01037400

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Total Knee Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Anthony Adili

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TKR Study

Identifier Type: -

Identifier Source: org_study_id

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