Clinical trials: Periprosthetic Joint Infection (PJI)
Prosthetic Joint Infection
Abbreviated Protocol for Two-Stage Exchange
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days).
- Trial name
- APEX (NCT04662632)
- Testing
- VT-X7 Treatment System with Tobramycin Sulfate, Standard of Care, Two-stage exchange arthroplasty
- Where
- 17 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Periprosthetic Joint Infection (PJI), Malnutitrion
Impact of Nutritional Status Before Joint Replacement on Infection Risk
Periprosthetic joint infection (PJI) is a serious complication after joint replacement surgery and is difficult to treat. Poor nutritional status may impair the body's ability to recover and fight infection, as well as increase…
- Conditions
- Periprosthetic Joint Infection (PJI), Malnutitrion, Postoperative Complication
- Trial name
- CONUT (Control (NCT07884006)
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Assiut University
Periprosthetic Joint Infection (PJI)
Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?
This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection.
- Trial name
- NCT05117671
- Testing
- data collection to classify infection status
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 1,554 people
- Sponsor
- University Hospital, Basel, Switzerland
Periprosthetic Joint Infection (PJI)
Preop Biomarkers as Outcome Predictors in 2 Stage Revision Surgery for PJI
With the progressive ageing of the population, a significant increase in the incidence of skeletal fractures-particularly of the proximal femur-as well as degenerative conditions such as osteoarthritis has been observed, for…
- Trial name
- ARKO-PJI (NCT07358455)
- Volunteers
- 200 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Periprosthetic Joint Infections
Laser Disinfection in Periprosthetic Joint Infection
The eradication of biofilms from infected implants is still an unsolved challenge. The high-energy light beam of an Er:YAG laser causes rapid heating and explosive ablation of tissue.
- Trial name
- NCT06440564
- Testing
- Er:YAG Laser irradiation
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Medical University of Vienna
Total Knee Arthroplasty, Reinfection
Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies
A single-center retrospective cohort study was conducted in the Department of Orthopedics, the First Affiliated Hospital of Fujian Medical University.
- Conditions
- Total Knee Arthroplasty, Reinfection, Aseptic Loosening, Revision
- Trial name
- NCT07232771
- Where
- China
- Volunteers
- 200 people
- Sponsor
- First Affiliated Hospital of Fujian Medical University
PJI
Infection Consortium Study#1
In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI.
- Trial name
- NCT06153446
- Testing
- Synovasure® Comprehensive Infection Panel
- Where
- United States
- Volunteers
- 810 people
- Sponsor
- Zimmer Biomet
Chronic Periprosthetic Joint Infection, Suspected Periprosthetic Joint Infection
Joint Endoprostheses Can Succesfully Treat Disabling Osteoarthritis. However, Infection is an Important Cause of Failure. Adequate Diagnostics Remains Challenging. Combining Advanced Imaging With Next-generation Sequencing of Samples Obtained Endoscopically Should Aid in Mapping and Characterizing.
This prospective observational diagnostic study aims to improve the accuracy and timeliness of diagnosing chronic periprosthetic joint infection (PJI).
- Conditions
- Chronic Periprosthetic Joint Infection, Suspected Periprosthetic Joint Infection, Prosthetic Joint Failure of Unclear Etiology
- Trial name
- PJI MAP/DEF (NCT07494630)
- Testing
- Comprehensive Diagnostic Work-up for Suspected Chronic Periprosthetic Joint Infection
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- University Hospital, Ghent
Periprosthetic Joint Infection (PJI)
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
This is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and…
- Trial name
- NCT06889701
- Testing
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection (IA), Vancomycin Hydrochloride for Injection (IV)
- Where
- China
- Volunteers
- 33 people
- Sponsor
- TenNor Therapeutics Inc.
Knee; Infection, Joint
Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer
A novel polyethylene-based knee spacer (United Cellbrick Knee Spacer), for the purpose of infection control, was developed to enhance biomechanical safety and surgical convenience of articulating knee spacers.
- Trial name
- NCT06042062
- Testing
- Novel spacer, Spacer
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- Chang Gung Memorial Hospital
Periprosthetic Joint Infection (PJI), Periprosthetic Knee Infection
Analysis of the Etiopathogenesis of Postoperative Complications in Orthopedic Patients Using Knee and Hip Arthroplasty as an Example
Relevance and Rationale Due to the widespread development of high-tech medical care in traumatology and orthopedics for patients with severe forms of hip and knee osteoarthritis and aseptic necrosis, and the increasing number of…
- Conditions
- Periprosthetic Joint Infection (PJI), Periprosthetic Knee Infection, Periprosthetic Hip Infection, Diagnostic
- Trial name
- NCT07813832
- Where
- Russia
- Volunteers
- 750 people
- Sponsor
- People's Friendship University of Russia
Bone and Join Infection (BJI), Periprosthetic Joint Infection (PJI)
Prospective Study of Patients Treated for Bone and Joint Infection (BJI) Due to Staphylococcus Aureus, Aiming at Identifying Biomarkers of Diagnosis Interest in Chronic BJI
There are more than one million (> 40,000 cases per year in France) of osteoarticular infections (OAI) yearly in the world. The number of these infections is constantly increasing due to an increase in life expectancy associated…
- Trial name
- ESPRI-IOAC (NCT04583241)
- Testing
- Constitution of serum bank at D0, Constitution of serum bank during follow-up, ELISA assays of serum markers of bone remodeling at D0
- Where
- France
- Volunteers
- 28 people
- Sponsor
- Hospices Civils de Lyon
Infection, Surgical Site Infection
Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty
The primary aim of the study is to compare two methods for a relationship with total knee infection: regular changing of dressings and not changing dressings.
- Conditions
- Infection, Surgical Site Infection, Prosthetic Infection, Wound Infection
- Trial name
- NCT04346875
- Testing
- Regularly changing of dressing, No application
- Volunteers
- 842 people
- Sponsor
- Bezmialem Vakif University
Periprosthetic Joint Infection, PJI
Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID
The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.
- Trial name
- MID (NCT05320354)
- Testing
- Microbial ID test
- Where
- 6 sites in Germany, Netherlands and 4 more
- Volunteers
- 200 people
- Sponsor
- UMC Utrecht
Dihydrotestosterone, Periprosthetic Joint Infection (PJI)
Finasteride and Cutibacterium
High levels of Testosterone causes high amounts of skin bacteria (Cutibacterium Acnes) which can go into the skin during a shoulder replacement surgery and cause a terrible infection.
- Conditions
- Dihydrotestosterone, Periprosthetic Joint Infection (PJI), Cutibacterium Acnes
- Trial name
- NCT07731802
- Testing
- Finasteride 1 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Washington
Prosthetic Joint Infection of Knee
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
The goal of this clinical trial is to learn whether the Sola2 AMF Knee System, when added to surgery and antibiotic treatment, can safely improve outcomes, knee function, and quality of life in adults with knee implant infection.
- Trial name
- AMPLIFY (NCT07700927)
- Testing
- Intervention 1: Alternating Magnetic Field Treatment, Debridement, Antibiotics, Implant Retention
- Volunteers
- 165 people
- Sponsor
- Solenic Medical, Inc.
Periprosthetic Joint Infection (PJI)
Efficacy of Serum ESR, CRP, Synovial Leucocyte Esterase Dipstick Test in The Diagnosis of Chronic Infection in Total Joint Arthroplasty
aim of this study was to determine accuracy of using leucocyte esterase (LE),Erythroscyte sedimentation rates (ESR) and C- Reactive protein (CRP) for diagnosing periprosthetic joint infections (PJI)
- Trial name
- ESR/CRP/LE pji (NCT07718386)
- Testing
- CRP, ESR, Leukocyte esterase dipstick test
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Ain Shams University
Knee Arthropathy, PJI
Incidence and Microbial Profiles of Periprosthetic Joint Infection After Total Knee Arthroplasty in Obese vs Non-Obese Patients
Importance: After a primary total knee arthroplasty (TKA), we anticipate that obese individuals are more likely to experience a of periprosthetic joint infection (PJI).
- Trial name
- NCT07398742
- Where
- Denmark
- Volunteers
- 101,299 people
- Sponsor
- Bispebjerg Hospital
Periprosthetic Joint Infection (PJI)
Periprosthetic Joint Infection Bubble Study
Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50/50 in the active and control…
- Trial name
- PJI (NCT07599865)
- Testing
- Ultrasound-triggered microbubble destruction with antibiotics
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Thomas Jefferson University
Periprosthetic Joint Infection (PJI)
Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections
The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment…
- Trial name
- MOLPJI (NCT06804265)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna