Clinical trials: Replacement
Arthroplasty, Replacement
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04786119
- Testing
- CORI Robotics
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Smith & Nephew, Inc.
Hip Replacement Arthroplasty
AMIStem-H Radiological Assessment
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.
- Trial name
- NCT03505580
- Where
- 2 sites in France
- Volunteers
- 500 people
- Sponsor
- Medacta International SA
Arthropathy, Knee Replacement
The Medacta GMK SpheriKA Post-Marketing Surveillance Study
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
- Trial name
- NCT05459948
- Testing
- GMK SpheriKA
- Where
- 4 sites in France, Italy and 1 more
- Volunteers
- 281 people
- Sponsor
- Medacta International SA
Arthroplasty, Replacement, Knee
Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.
- Trial name
- NCT00733915
- Testing
- L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)
- Where
- Ireland
- Volunteers
- 241 people
- Sponsor
- DePuy International
Postoperative Pain, Total Knee Replacement
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg.
- Conditions
- Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement
- Trial name
- NCT04341948
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 10 sites in United States
- Volunteers
- 56 people
- Sponsor
- SPR Therapeutics, Inc.
Arthroplasty, Replacement
Evaluate the Performance of JOURNEY II CR in TKA Populations
Background: The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II CR Total Knee System Objectives: Evaluate the…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- JIICRTKA (NCT04818840)
- Testing
- Resurfaced Patella, Un-resurfaced Patella
- Where
- 8 sites in China, India and 3 more
- Volunteers
- 62 people
- Sponsor
- Smith & Nephew, Inc.
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Aortic Valve Stenosis, Aortic Valve Disease
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
- Trial name
- NCT05295628
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS"), SENTINEL™ Cerebral Protection System
- Where
- 23 sites in United States
- Volunteers
- 532 people
- Sponsor
- Emblok, Inc.
Knee Arthroplasty, Total, Partial Knee Replacement
Exactech Knee Systems Post Market Clinical Follow-up
This is a multi-center, open-label, prospective and retrospective clinical outcomes study. Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices.
- Trial name
- NCT07107581
- Testing
- Prospective / Subjects Knee Arthroplasty, Retrospective to Prospective, Retrospective Only Subjects
- Where
- United States
- Volunteers
- 1,879 people
- Sponsor
- Exactech
Arthroplasty, Replacement, Hip
Secur-Fit Advanced Outcomes Study
The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.
- Trial name
- NCT01917929
- Testing
- Secur-Fit Advanced Hip Stem
- Where
- 8 sites in United States
- Volunteers
- 326 people
- Sponsor
- Stryker Orthopaedics
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT).
- Conditions
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury
- Trial name
- NCT02860130
- Testing
- Prismocitrate 18, No Anticoagulation
- Where
- 12 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Vantive Health LLC
Bleeding, Bypass Complication
A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding.
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Trial name
- NCT05542277
- Testing
- ClearPlasma
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 130 people
- Sponsor
- PlasFree Ltd.
Postoperative Anemia, Arthroplasty, Replacement, Hip
Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
To assess the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of orally administered SSS17 capsules in patients with postoperative anemia following elective total hip or knee…
- Conditions
- Postoperative Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Trial name
- NCT07007936
- Testing
- SSS17 Capsule (6 Dose Levels)
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Transcatheter Aortic Valve Replacement
Cara CDRM (Conduction Disturbance Risk Monitor) 2.0
Prospective, multicenter, roll-in, pilot clinical trial. Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed for New-Onset Conduction Disturbances (NOCD).
- Trial name
- Cara CDRM (NCT05465655)
- Testing
- ECG monitoring for Conduction Disturbances
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Cara Medical Ltd
Transcatheter Aortic Valve Replacement, Conduction Disturbance
Intra-procedural ECG Changes During TAVR
The purpose of this study is to evaluate electrocardiogram (ECG) changes in 100 patients undergoing transcatheter aortic valve replacement (TAVR) to assess new-onset conduction abnormalities, such as atrioventricular nodal block…
- Trial name
- NCT05791344
- Testing
- ECG monitoring
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Cara Medical Ltd
Transcatheter Aortic Valve Replacement
Cara CDRS (Conduction Disturbance Risk Score) 1.0
Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study. Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD…
- Trial name
- CDRS (NCT05657912)
- Testing
- ECG monitoring
- Where
- 3 sites in Canada, Italy and 1 more
- Volunteers
- 355 people
- Sponsor
- Cara Medical Ltd
Arthroplasties, Knee Replacement, Revision Arthroplasty
Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow…
- Trial name
- NCT06203756
- Testing
- Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
- Where
- 6 sites in United States
- Volunteers
- 713 people
- Sponsor
- Corin
Mitral Valve or Aortic Valve Replacement
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.
- Trial name
- NCT02523066
- Testing
- Magna Ease
- Where
- China
- Volunteers
- 215 people
- Sponsor
- Edwards Lifesciences
Arthroplasties, Knee Replacement
A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement
This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement.
- Trial name
- NCT02527148
- Testing
- OtisMed® ShapeMatch® Technology, Stryker Precision Knee Navigation, Total Knee Replacement
- Volunteers
- 100 people
- Sponsor
- Stryker South Pacific
Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- GUARDIAN (NCT06962371)
- Testing
- cerebral embolic protection
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Transverse Medical, Inc.