Clinical trials: TKA
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.
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
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
Degenerative Arthritis of Knee
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched…
- Trial name
- NCT01084772
- Testing
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Where
- 7 sites in United States, Australia
- Volunteers
- 134 people
- Sponsor
- Smith & Nephew, 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
Musculoskeletal Diseases
Medacta NextAR TKA Pivotal Trial
The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).
- Trial name
- NCT04844879
- Testing
- NextAR TKA system
- Where
- 4 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Medacta International SA
Arthroplasty, Replacement
Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
Background: The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM) The JOURNEY II CR Total Knee System (JOURNEY II Cruciate…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- JIICRBCSTKA (NCT04822259)
- Testing
- JOURNEY II BCS Total Knee System, JOURNEY II CR Total Knee System
- Where
- 5 sites in China, India and 1 more
- Sponsor
- Smith & Nephew, Inc.
Total Knee Arthroplasty
Treatment With Iovera° for Total Knee Arthroplasty (TKA) Post-Operative Pain
This study is designed to investigate whether iovera° treatment prior to TKA decreases cumulative participant opioid use over the course of 6 weeks following TKA while maintaining similar levels of pain relief.
- Trial name
- NCT03327220
- Testing
- iovera°
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Total Knee Arthroplasty
NEUROCUPLE™ in TKA Patients to Enhance Pain Management
This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA.
- Trial name
- NCT06460350
- Testing
- NEUROCUPLE™ Patch
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- nCap Medical
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using…
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome, Patient Satisfaction
- Trial name
- ORTHOPATH (NCT05182320)
- Testing
- OrthoPath, Control
- Where
- 2 sites in Germany
- Sponsor
- Aesculap AG
Total Knee Arthroplasty (TKA)
Does an Active Range of Motion Monitor Improve Outcomes/Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.
- Trial name
- NCT05310474
- Testing
- Knee Glider
- Volunteers
- 200 people
- Sponsor
- Force Therapeutics
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.
Osteoarthritis, Rheumatoid Arthritis
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis
- Trial name
- NCT00289107
- Testing
- Total Knee Arthroplasty, Total knee replacement
- Where
- 3 sites in United States
- Volunteers
- 149 people
- Sponsor
- DePuy Orthopaedics
Osteoarthritis, Post-traumatic Arthritis
A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis
A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT05197036
- Testing
- Total Knee Arthroplasty
- Where
- 18 sites in United States, Australia and 3 more
- Volunteers
- 299 people
- Sponsor
- Smith & Nephew, Inc.
Postoperative Pain Management in Total Knee Arthroplasty
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management in total knee…
- Trial name
- NCT06509958
- Testing
- HR18034, Ropivacaine Hydrochloride Injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
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.
Osteoarthritis, Knee
TKA Operating Room Efficiency for TKA Using Customized Implant Techniques
This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee…
- Trial name
- NCT04180423
- Testing
- Off-the-Shelf Implant Total Knee Replacement, Customized Implant Total Knee Replacement
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Restor3D
Osteoarthritis, Rheumatoid Arthritis
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- Trial name
- NCT00839020
- Testing
- Navigated TKA with a minimally invasive approach, Navigated TKA with a conventional approach
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Aesculap AG
Osteoarthritis, Knee
A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.
- Trial name
- NCT03152162
- Testing
- iTotal PS KRS
- Where
- 4 sites in United States
- Volunteers
- 102 people
- Sponsor
- Restor3D
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