Clinical trials: Periprosthetic Hip Infection
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.
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.
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.
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.