Chronic Pain, Inflammation and Infection After Joint Replacement
Extended Biochemical Analysis and Bacteriologic Diagnosis in Patients With Loose Joint Replacements, Chronic Pain and Infection.
1 other identifier
observational
180
1 country
1
Brief Summary
Revision surgery after total hip or knee arthroplasty is an ongoing issue due to an increasing number of primary surgeries. Patients seek physicians due to pain. The cause is divided between loosening, infection or chronic pain. Some are operated on the suspicion of a chronic infection. However, postoperative microbiological testing does not always correlate with the suspicion and the operation may have been superfluous. The objective is to employ a highly advanced diagnostic algorithm based on state of the art diagnostic techniques in order to improve the basis of preoperative diagnosis. Through this approach treatment can be given according to the causal problem.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedApril 10, 2015
April 1, 2015
3.9 years
June 24, 2014
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Examination of blood test parameters
The outcome measure is a composite. In order to predict the risk of developing a serious infection we want to: * develop serum concentration markers * describe bacteriological diversity * perform qualitative assessment of pain and sensitization
4 years
Secondary Outcomes (2)
Collect systematic data
4 years
Generate a knowledge base
4 years
Study Arms (3)
40 patients (uTHA)
Patients undergoing primary uncemented total hip arthroplasty surgery.
40 patients (hTHA)
40 patients undergoing primary hybrid total hip replacement surgery.
40 patients (TKA)
40 patients undergoing total knee replacement surgery.
Interventions
4 x 10 ml blood samples.
Eligibility Criteria
Primary care clinic.
You may qualify if:
- Patients undergoing primary uncemented total hip-joint replacement surgery
- Patients undergoing primary hybrid total hip-joint replacement surgery
- Patients undergoing total knee-joint replacement surgery
You may not qualify if:
- Patients younger than 18 years old
- Unability to speak or read Danish
- Pregnancy or lactating
- Bilateral disease
- Cancer
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, 9000, Denmark
Biospecimen
4 x 10 ml blood samples for each patient.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sten Rasmussen, M.D.
Northern Orthopaedic Division, Aalborg University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 27, 2014
Study Start
January 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 10, 2015
Record last verified: 2015-04