Biochemical Approach to Measuring Surgical Trauma

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01037400

Enrollment

Registered

2009-12-23

Start date

2010-02-28

Completion date

Unknown

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

Keywords

Knee Replacement, Arthroplasty

Brief 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity and Specificity of biomarkers in response to tissue injury	7 days

Countries

Canada

Outcome results