Clinical trials: Prosthetic
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
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
- Trial name
- NCT05275088
- Testing
- Prizvalve® system
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Amputation
Stability and 3D Motion Study of an Experimental Prosthetic Foot
The investigators are currently verifying early data showing that the K3 Promoter prosthetic foot affects walking efficiency or stability in transtibial, unilateral amputees when compared to their current prostheses.
- Trial name
- NCT00968292
- Testing
- Experimental prosthetics foot (K3 Promoter)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Tensegrity Prosthetics
Atrial Fibrillation, Atrial Flutter
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease, Myocardial Infarction
- Trial name
- EmbraceAC (NCT00691470)
- Testing
- ATI-5923, Coumadin (warfarin)
- Where
- 41 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARYx Therapeutics
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
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
Jaw, Edentulous
Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants
Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants.
- Trial name
- NCT00922935
- Testing
- Cresco, Straumann components
- Where
- 2 sites in Sweden
- Volunteers
- 36 people
- Sponsor
- Institut Straumann 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
Peri-implantitis, Peri-implant Bone Loss
Access to Probing and Peri-implant Diseases
This multicenter cross-sectional study aims to evaluate the association between access to peri-implant probing and radiographic peri-implant bone loss.
- Trial name
- NCT07557459
- Testing
- Peri-implant probing
- Where
- 9 sites in Spain
- Volunteers
- 281 people
- Sponsor
- Arrow Development
Amputation
Pro APP Prosthetic Outcome Registry
A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.
- Trial name
- NCT06210620
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Prosthetic Joint Infection, Staphylococcus Aureus
Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection
This is an observational study that does not change routine care. The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according…
- Conditions
- Prosthetic Joint Infection, Staphylococcus Aureus, Biofilm
- Trial name
- BJIBiofilm (NCT03263832)
- Testing
- Antibiofilmogramme
- Where
- France
- Volunteers
- 45 people
- Sponsor
- BioFilm Control
Hernia
Feasibility of Permacol Use in Infected Fields
This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
- Trial name
- NCT00820040
- Testing
- acellular porcine dermal collagen mesh
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
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
Breast Reconstruction
DuraSorb® in Prosthetic Breast Reconstruction
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
- Trial name
- NCT04646057
- Testing
- DuraSorb®
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Surgical Innovation Associates, Inc.
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.
Transtibial Amputees
Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions
The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients…
- Trial name
- NCT04679701
- Testing
- Amparo Confidence Socket
- Where
- 2 sites in Kenya
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Amparo GmbH
Amputation, Prosthesis User
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
- Trial name
- NCT05190354
- Testing
- Xtremity Polymer Prosthetic Socket
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Medical Creations, 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