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| Name | Class |
|---|---|
| The Ministry of Science, Technology and Innovation, Denmark | OTHER_GOV |
| University of Aarhus | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | 4 x 10 ml blood samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Sten Rasmussen, M.D. | Northern Orthopaedic Division, Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Orthopaedic Division, Aalborg University Hospital | Aalborg | 9000 | Denmark |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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4 x 10 ml blood samples for each patient.
| 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. | 4 years |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |