Biochemical Approach to Measuring Surgical Trauma

NCT01037400 | Withdrawn

• 1 other identifier: TKR Study
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Total Knee Replacement

Keywords

Knee Replacement; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of biomarkers in response to tissue injury

  7 days

Study Arms (1)

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N4A6, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and Serum

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

CA (1)