Clinical trials: Prosthetic Treatment
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
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.
Hip Prosthesis Infection, Knee Prosthesis Infection
Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics.
- Trial name
- GLORIA (NCT06605651)
- Testing
- Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution, 0.9% NaCl solution
- Volunteers
- 100 people
- Sponsor
- Phagenix
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT06621251
- Testing
- TRL1068 (calpurbatug), a human monoclonal antibody, DAIR
- Where
- 11 sites in United States
- Volunteers
- 60 people
- Sponsor
- Trellis Bioscience LLC
Prosthetic-joint Infection
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement…
- Trial name
- RETAIN (NCT07214311)
- Testing
- PLG0206
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 240 people
- Sponsor
- Peptilogics
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.
Single Sided Deafness
Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
- Trial name
- NCT01933386
- Testing
- SoundBite
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Sonitus Medical Inc
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Urinary Incontinence
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are…
- Trial name
- ACT (NCT00113555)
- Testing
- ACT (Adjustable Continence Therapy)
- Where
- 7 sites in United States, Canada
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- Uromedica
Hyperhidrosis, Residual Limbs
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.
- Trial name
- NCT05501444
- Testing
- Topical antiperspirant
- Where
- Norway
- Volunteers
- 7 people
- Sponsor
- Sophies Minde Ortopedi
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
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.
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)
Heart Valve Stenosis
ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
- Trial name
- NCT01264484
- Testing
- Advantage Prosthetic Heart Valve
- Where
- 2 sites in Germany
- Volunteers
- 212 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
Infection
LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection
The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5…
- Trial name
- NCT00906048
- Testing
- Levofloxacin (HR355) and Rifampicin Therapy
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Sanofi
Prosthetic Joint Infection, Bacterial Infections
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without…
- Trial name
- ACTIVE1 (NCT05269121)
- Testing
- Phage Therapy
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Refractory Bone or Joint Infections
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
- Trial name
- NCT02569541
- Testing
- sodium fusidate
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Arrevus Inc.
Anti-coagulation Therapy, DVT
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to…
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple
- Trial name
- WARFARIN (NCT01305148)
- Testing
- Warfarin GenoSTAT Test
- Where
- 56 sites in United States
- Volunteers
- 3,800 people
- Sponsor
- Iverson Genetic Diagnostics, 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