Clinical trials: Periprosthetic Infection
Periprosthetic Joint Infections
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules + Tobramycin (EP G + T)…
- Trial name
- MAGIC (NCT05361941)
- Testing
- EP Granules with Tobramycin, empty voids
- Where
- 16 sites in United States
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Elute, Inc.
Periprosthetic Joint Infection
Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections
This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections.
- Trial name
- NCT06428448
- Testing
- REMEDY Spectrum IM Spacer Nail
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- OsteoRemedies, LLC
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.
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants…
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability
- Trial name
- NCT07653295
- Testing
- Tıpmed™ Revision Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 35 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
Peri-Prosthetic Joint Infection
IP-coated Revision Hip Implants
The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic…
- Trial name
- HIPrevision (NCT06737809)
- Testing
- IP Plasmafit® Revision cup (and stem) system
- Where
- 2 sites in Germany, Poland
- Volunteers
- 268 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.
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
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.
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
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.
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
- Where
- 2 sites in United States
- Volunteers
- 165 people
- Sponsor
- Solenic Medical, Inc.
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
Joint Infection
Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for…
- Trial name
- NCT05137314
- Testing
- PLG0206
- Where
- 12 sites in United States
- Volunteers
- 14 people
- Sponsor
- Peptilogics
Periprosthetic Joint Infection
Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid
To demonstrate the tests' performance when compared to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI.1 This criteria-based definition of PJI places…
- Trial name
- NCT02868736
- Testing
- Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- CD Diagnostics