NCT01322074

Brief Summary

In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 17, 2011

Status Verified

October 1, 2011

Enrollment Period

2.2 years

First QC Date

March 23, 2011

Last Update Submit

October 14, 2011

Conditions

Other Acute Postoperative PainSystemic Inflammatory Response Syndrome

Keywords

Acute postoperative painsystemic inflammationCRPIL6

Outcome Measures

Primary Outcomes (1)

  • Systemic inflammation vs. pain

    The correlation between pain and systemic inflammatory markers (CRP and IL6)

    1 week

Study Arms (1)

Total knee arthroplasty

Patients operated with elective, unilateral total knee arthroplasty.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients operated with total knee arthroplasty

You may qualify if:

  • Elective unilateral primary total knee arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

You may not qualify if:

  • Alcohol or medical abuse
  • Allergies to local anesthetics or methylprednisolone
  • Age \< 18 years old
  • Daily use of strong opioids or glucocorticoids
  • Pregnancy or breastfeeding (fertile women)
  • Bilateral / revision arthroplasty
  • Dementia or other cognitive dysfunction
  • Diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anesthsiology, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for C reactive protein and interleukin 6 analysis.

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromePain, Postoperative

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 17, 2011

Record last verified: 2011-10

Locations

DK(1)