Clinical trials: Infection; Knee, Joint
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Prosthetic Joint Infections
[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
- Trial name
- PJI (NCT01705496)
- Testing
- [124I]FIAU
- Where
- 10 sites in United States
- Volunteers
- 23 people
- Sponsor
- BioMed Valley Discoveries, Inc
Prosthetic Joint Infection
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
- Trial name
- ACTIVE2 (NCT05269134)
- Testing
- Bacteriophage
- Where
- 10 sites in United States
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Prosthetic Joint Infection
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
- Trial name
- NCT04787250
- Testing
- Phage Therapy, Two-Stage Exchange Arthroplasty
- Where
- United States
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Infection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee…
- Trial name
- NCT02266407
- Testing
- Aquamantys System
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Prosthetic-joint Infection
Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty
The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment…
- Trial name
- APEX-EAP (NCT06383611)
- Testing
- VT-X7 Treatment System
- Where
- 14 sites in United States
- Sponsor
- Osteal Therapeutics, Inc.
Infection of Total Hip Joint Prosthesis, Infection of Total Knee Joint Prosthesis
Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication…
- Trial name
- PhagoDAIRI (NCT05369104)
- Testing
- Anti-Staphylococcus aureus Bacteriophages
- Where
- France
- Volunteers
- 64 people
- Sponsor
- Phagenix
Prosthetic Joint Infection (PJI)
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with…
- Trial name
- NCT07858916
- Testing
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection, Oral antibiotics
- Where
- China
- Volunteers
- 40 people
- Sponsor
- TenNor Therapeutics (Zhongshan) Limited
Infection of Total Knee Joint Prosthesis
Evaluating Bactisure Wound Lavage in Orthopedic Wounds
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
- Trial name
- NCT03192124
- Testing
- Bactisure
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Arthroplasty, Arthroplasty Replacement, Knee
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
- Conditions
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
- Trial name
- oneKNEE (NCT07682909)
- Testing
- oneKNEE®
- Volunteers
- 1,020 people
- Sponsor
- Aesculap AG
Prosthetic-joint Infection
A Second Trial of the Abbreviated Protocol Two-Stage Exchange
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm.
- Trial name
- Apex-2 (NCT05607030)
- Testing
- VT-X7 Treatment System, Two-stage exchange arthroplasty, SOC Antibiotics
- Where
- 19 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Prosthetic Joint Infection
Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA).
- Trial name
- NCT04294862
- Testing
- TNP-2092
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- TenNor Therapeutics Limited
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections
- Conditions
- Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers
- Trial name
- NCT01756924
- Testing
- CEM-102, IV or Oral standard of care antibiotics, Rifampin
- Where
- 13 sites in United States
- Volunteers
- 14 people
- Sponsor
- Arrevus Inc.
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.
Prosthesis Related Infections
Biodistribution and Dosimetry Evaluation of [124I]FIAU
This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy volunteers and patients with prosthetic joint infections.
- Trial name
- NCT01337466
- Testing
- [124I]FIAU
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- BioMed Valley Discoveries, Inc
Osteoarthritis, Arthritis
Bipolar Sealer Aquamantys Use in Total Knee Replacement
This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery.
- Conditions
- Osteoarthritis, Arthritis, Surgery, Infection
- Trial name
- NCT01736644
- Testing
- Electrocautery, Bipolar sealer Aquamantys
- Where
- 2 sites in United Kingdom
- Volunteers
- 97 people
- Sponsor
- Medtronic Surgical Technologies
Aseptic Loosening, Infection
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
- Conditions
- Aseptic Loosening, Infection, Bone Loss, MCL - Medial Collateral Ligament Rupture of the Knee
- Trial name
- NCT03312088
- Testing
- Freedom Knee PCK Components
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Maxx Orthopedics Inc
Osteomyelitis
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci.
- Trial name
- NCT00428844
- Testing
- daptomycin, vancomycin, teicoplanin
- Where
- 26 sites in United States, Russia and 1 more
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Prosthetic Joint Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the…
- Trial name
- NCT03721328
- Testing
- vancomycin hydrochloride and tobramycin sulfate
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Osteal Therapeutics, Inc.