Recruitment

Recruitment Status
Completed
Estimated Enrollment
200

Inclusion Criterias

Patients undergoing primary hybrid total hip-joint replacement surgery
Patients undergoing primary uncemented total hip-joint replacement surgery
Patients undergoing total knee-joint replacement surgery
Patients undergoing primary hybrid total hip-joint replacement surgery
Patients undergoing primary uncemented total hip-joint replacement surgery
Patients undergoing total knee-joint replacement surgery

Exclusion Criterias

Bilateral disease
Cancer
Pregnancy or lactating
...
Bilateral disease
Cancer
Pregnancy or lactating
Patients younger than 18 years old
Inability to give informed consent
Unability to speak or read Danish

Summary

Conditions
  • Infection and Inflammatory Reaction
  • Joint Prosthesis
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Retrospective

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

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 comm...

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.

Inclusion Criterias

Patients undergoing primary hybrid total hip-joint replacement surgery
Patients undergoing primary uncemented total hip-joint replacement surgery
Patients undergoing total knee-joint replacement surgery
Patients undergoing primary hybrid total hip-joint replacement surgery
Patients undergoing primary uncemented total hip-joint replacement surgery
Patients undergoing total knee-joint replacement surgery

Exclusion Criterias

Bilateral disease
Cancer
Pregnancy or lactating
...
Bilateral disease
Cancer
Pregnancy or lactating
Patients younger than 18 years old
Inability to give informed consent
Unability to speak or read Danish

Locations

Aalborg, 9000
Aalborg, 9000

Tracking Information

NCT #
NCT02177097
Collaborators
  • The Ministry of Science, Technology and Innovation, Denmark
  • University of Aarhus
Investigators
  • Principal Investigator: Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital
  • Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital