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Clinical Trial Summary

The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.


Clinical Trial Description

The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02424903
Study type Observational
Source Pro-Implant Foundation
Contact Maren Engel
Phone +4930450652417
Email maren.engel@charite.de
Status Not yet recruiting
Phase N/A
Start date May 2015
Completion date December 2018

See also
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Active, not recruiting NCT03121183 - Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers N/A
Completed NCT04622280 - Prospectively Observational Evaluation of Clinical Outcomes in Two-stage Revision for Periprosthetic Knee Infection
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Completed NCT01760863 - Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty N/A
Completed NCT06089044 - Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
Recruiting NCT03444571 - PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections N/A
Completed NCT03274466 - Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty N/A
Completed NCT02860767 - Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses N/A
Completed NCT01175044 - Dilute Betadine Lavage in the Prevention of Postoperative Infection Phase 4
Recruiting NCT02376153 - Air Barrier System for the Prevention of Prosthesis-related Infections N/A
Active, not recruiting NCT00423982 - Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty Phase 4