Joint Prosthesis Clinical Trial
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.
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:
1. describe the postoperative course of specific serologic markers for primary and
secondary total hip arthroplasty (THA) and total knee arthroplasty (TKA).
2. 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.
3. describe pain and sensitization with new diagnostic technology in patients with stem
loosening, suffering from infection and pain.
4. 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.
5. describe the effect of the diagnostic algorithm, compared with a descriptive
retrospective cohort of patients who have undergone revision of THA or TKA.
;
Observational Model: Cohort, Time Perspective: Retrospective
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