Infection and Inflammatory ReactionNCT02177097
Chronic Pain, Inflammation and Infection After Joint Replacement
An observational study of Infection and Inflammatory Reaction and Joint Prosthesis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infection and Inflammatory Reaction, Joint Prosthesis
- What is being tested?
- Blood samples
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- 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
Who cannot join
- Patients younger than 18 years old
- Unability to speak or read Danish
- Pregnancy or lactating
- Bilateral disease
- Cancer
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: Extended Biochemical Analysis and Bacteriologic Diagnosis in Patients With Loose Joint Replacements, Chronic Pain and Infection.
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.
Read the detailed description
The aim of the project is to improve the preoperative diagnosis of infections and persistent pain in patients with prosthesis-related problems. Prosthesis infection is of chronic nature. Recent research has shown that one important explanation of this is the formation of encapsulated 'bacterial communities' on the surface of the prosthesis, where bacteria are well protected against antibiotic treatment. Surgery is therefore necessary for this patient group. But it is important to make diagnosis more accurate than it currently is today. In contrast, patients with persistent pain, but no indication of infection or prosthetic loosening, are best served by avoiding surgery, and instead receiving a treatment that is directed against the chronic pain condition. Based on the pain research carried out at Aalborg University, an understanding of chronic pain and treatment principles that would be beneficial for this patient group have been developed.
The investigators want to:
- describe the postoperative course of specific serologic markers for primary and secondary total hip arthroplasty (THA) and total knee arthroplasty (TKA).
- describe the bacteriologic diversity through revision of THA and TKA using cultivation techniques and molecular biological analysis comprehensive fluorescence in-situ hybridization (FISH), cloning and phylogeny, quantitative polymerase chain reaction (qPCR) and gene expression profiling.
- describe pain and sensitization with new diagnostic technology in patients with stem loosening, suffering from infection and pain.
- apply to a new diagnostic algorithm for the diagnosis of infection and pain following THA and TKA, which includes pain assessment, diagnostic X-ray, bone scintigraphy, PET scan, percutaneous biopsy, specific serologic parameters and molecular biological analysis.
- describe the effect of the diagnostic algorithm, compared with a descriptive retrospective cohort of patients who have undergone revision of THA or TKA.
- Being tested
- Blood samples
- Keywords
- Pain, Infection, Inflammation, Prosthesis
- Medical subject headings
- Infections, Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
4 x 10 ml blood samples.
| Study group | Role | What they receive |
|---|---|---|
| 40 patients (uTHA) | Patients undergoing primary uncemented total hip arthroplasty surgery. Receives: Biological: Blood samples | |
| 40 patients (hTHA) | 40 patients undergoing primary hybrid total hip replacement surgery. Receives: Biological: Blood samples | |
| 40 patients (TKA) | 40 patients undergoing total knee replacement surgery. Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (2)
Collect systematic data
The outcome measure is a composite. We want to collect systematic collect systematic data with a view to identify which specific blood parameters can best predict the risk that the patient develops a serious infection. Furthermore, we want to collect systematic data with a view to optimize the diagnostic algorithm.
Measured: 4 years
Generate a knowledge base
The outcome measure is a composite. We want to generate a knowledge base for optimal antibiotic treatment, optimal pain management, optimal treatment of infection and pain caused by THA and TKA.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection and Inflammatory ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177097
- Sponsor's protocol ID
- N-20110022
- Status last verified
- Apr 2015
- First submitted
- 24 Jun 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Biochemical Analysis and Bacteriologic Diagnosis in Patients With Loose Joint Replacements, Chronic Pain and Infection.
- ClinicalTrials.gov ID
- NCT02177097
- Acronym / sponsor ID
- N-20110022
- Keywords
- Pain, Infection, Inflammation, Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, University of Aarhus
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the project is to improve the preoperative diagnosis of infections and persistent pain in patients with prosthesis-related problems. Prosthesis infection is of chronic nature. Recent research has shown that one important explanation of this is the formation of encapsulated 'bacterial communities' on the surface of the prosthesis, where bacteria are well protected against antibiotic treatment. Surgery is therefore necessary for this patient group. But it is important to make diagnosis more accurate than it currently is today. In contrast, patients with persistent pain, but no indication of infection or prosthetic loosening, are best served by avoiding surgery, and instead receiving a treatment that is directed against the chronic pain condition. Based on the pain research carried out at Aalborg University, an understanding of chronic pain and treatment principles that would be beneficial for this patient group have been developed.
The investigators want to:
- describe the postoperative course of specific serologic markers for primary and secondary total hip arthroplasty (THA) and total knee arthroplasty (TKA).
- describe the bacteriologic diversity through revision of THA and TKA using cultivation techniques and molecular biological analysis comprehensive fluorescence in-situ hybridization (FISH), cloning and phylogeny, quantitative polymerase chain reaction (qPCR) and gene expression profiling.
- describe pain and sensitization with new diagnostic technology in patients with stem loosening, suffering from infection and pain.
- apply to a new diagnostic algorithm for the diagnosis of infection and pain following THA and TKA, which includes pain assessment, diagnostic X-ray, bone scintigraphy, PET scan, percutaneous biopsy, specific serologic parameters and molecular biological analysis.
- describe the effect of the diagnostic algorithm, compared with a descriptive retrospective cohort of patients who have undergone revision of THA or TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40 patients (uTHA) | – | Biological: Blood samplesPatients undergoing primary uncemented total hip arthroplasty surgery. |
| 40 patients (hTHA) | – | Biological: Blood samples40 patients undergoing primary hybrid total hip replacement surgery. |
| 40 patients (TKA) | – | Biological: Blood samples40 patients undergoing total knee replacement surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Patients younger than 18 years old
- Unability to speak or read Danish
- Pregnancy or lactating
- Bilateral disease
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples4 x 10 ml blood samples. | Biological | 40 patients (TKA), 40 patients (hTHA), 40 patients (uTHA) |
Primary outcome
Examination of blood test parameters
Time frame: 4 years
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
2 secondary outcomes
Collect systematic data
Time frame: 4 years
Generate a knowledge base
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Related trials for Infection and Inflammatory Reaction
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 2
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Abscess
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, M.D. principal investigator
Northern Orthopaedic Division, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Inflammatory Reaction and Joint Prosthesis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination of blood test parameters (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.