Clinical trials: TKA
Knee Osteoarthritis
Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors.
- Trial name
- NCT03023410
- Testing
- VERASENSE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Orthosensor, Inc.
Osteoarthritis, Rheumatoid Arthritis
PS150 Total Knee Arthroplasty Outcomes Registry
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years.
- Trial name
- NCT02319291
- Testing
- P.F.C. Sigma PS150 RP Total Knee System
- Where
- 4 sites in Australia, South Korea
- Volunteers
- 175 people
- Sponsor
- DePuy Orthopaedics
Inflammatory Arthritis, Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis)
A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)
The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets.
- Conditions
- Inflammatory Arthritis, Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis), Post-traumatic Arthritis
- Trial name
- NCT07199738
- Testing
- Cemented CoCr, Cemented Oxinium, Cementless
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- Smith & Nephew, Inc.
Total Knee Arthroplasty
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）
This is a randomized, double-blind, active-controlled, multicenter, phase II clinical study designed to evaluate the efficacy and safety of BT-114143 Injection in the perioperative treatment of unilateral total knee arthroplasty.
- Trial name
- TKA (NCT07127042)
- Testing
- Low-dose BT-114143, High-dose BT-14143, Tranexamic Acid (IV)
- Where
- China
- Volunteers
- 270 people
- Sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
Symptomatic Venous Thromboembolism (VTE)
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA).
- Trial name
- ROXI-ASPEN (NCT07213778)
- Testing
- REGN7508, Acetylsalicylic Acid (ASA)
- Where
- 51 sites in United States, Greece and 3 more
- Volunteers
- 2,000 people
- Sponsor
- Regeneron Pharmaceuticals
Total Knee Replacement
ORIGIN® PS Modular & Associated Instruments
The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision…
- Trial name
- NCT06628050
- Testing
- ORIGIN® PS Modular devices
- Where
- 2 sites in France
- Volunteers
- 200 people
- Sponsor
- Symbios Orthopedie SA
Opioid Use, Arthropathy of Knee
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA).
- Conditions
- Opioid Use, Arthropathy of Knee, Pain, Postoperative
- Trial name
- NCT04010266
- Testing
- RelieVRx headset, multi-modality pain management
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- AppliedVR Inc.
Osteoarthritis
Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study
The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure.
- Trial name
- NCT00733330
- Testing
- Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique, Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 86 people
- Sponsor
- DePuy International
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.
Knee Disease
Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer…
- Trial name
- NCT04578951
- Testing
- FHK® total knee prosthesis
- Where
- France
- Volunteers
- 50 people
- Sponsor
- FH ORTHO
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
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Osteoarthritis, Knee
Vanguard TKA With KneeAlign 2 and Without KneeAlign 2
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments
- Trial name
- NCT02695329
- Testing
- KneeAlign 2
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Total Knee Replacement
A Post-market Observational ORIGIN® CR Clinical Study
The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e.
- Trial name
- NCT05607966
- Testing
- ORIGIN® CR devices
- Where
- 2 sites in Belgium
- Volunteers
- 199 people
- Sponsor
- Symbios Orthopedie SA
Knee Pain Chronic, Osteoarthritis
Persona Total Knee Arthroplasty Outcomes Study
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty.
- Conditions
- Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- NCT02255383
- Testing
- Zimmer Persona Total Knee System
- Where
- 14 sites in United States
- Volunteers
- 737 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Knee
JOURNEY™ II CR Total Knee System
The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.
- Trial name
- NCT02440672
- Testing
- JOURNEY™ II CR Total Knee System (J II CR TKS)
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Post-traumatic Arthritis
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable…
- Trial name
- SOLO (NCT02574312)
- Testing
- ATTUNE TKA with ATTUNE RUI, ATTUNE TKA with ATTUNE SUI
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 88 people
- Sponsor
- DePuy Orthopaedics
Total Knee Arthroplasty
MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention
The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA).
- Trial name
- NCT05544409
- Testing
- MAKv1
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- MarsiBionics
Degenerative Osteoarthritis, Rheumatoid Arthritis
All Polyethylene Tibia-VEGA Kiel
Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and…
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Post-traumatic; Arthrosis, Other Instability, Knee
- Trial name
- APT-VEGA_KI (NCT02756702)
- Testing
- All-Poly
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Aesculap AG
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