Clinical trials: Primary Total Knee Arthroplasty
Knee Osteoarthritis, Post-traumatic Osteoarthritis
Establish Implant Accuracy With X-PSI Knee System
The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical alignment and compare them with preoperative…
- Trial name
- X-PSI (NCT03275246)
- Testing
- X-PSI Knee System
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 8 people
- Sponsor
- Zimmer, GmbH
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
Non-inflammatory Degenerative Joint Disease
A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System…
- Trial name
- NCT02650284
- Testing
- Stryker Triathlon Primary Total Knee System, Restoris MCK Multicompartmental Knee System
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Stryker South Pacific
Osteoarthritis of the Knee
MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty
Overall study design: A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system.
- Trial name
- MIS GEN II (NCT00853398)
- Testing
- surgical technique
- Where
- Germany
- Sponsor
- Smith & Nephew Orthopaedics AG
Osteoarthritis, Post-traumatic Arthritis
Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Gout, Pseudo-gout
- Trial name
- NCT01529099
- Testing
- SIGMA HP PARTIAL KNEE
- Where
- 3 sites in Italy, Switzerland
- Volunteers
- 64 people
- Sponsor
- DePuy International
Total Knee Replacement, Total Hip Replacement
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs.
- Trial name
- NCT00074828
- Testing
- LY517717, enoxaparin
- Where
- 8 sites in Australia, Austria and 6 more
- Volunteers
- 511 people
- Sponsor
- Eli Lilly and Company
Primary Knee Arthroplasty
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing…
- Trial name
- NCT03153449
- Testing
- ATTUNE Revision Knee System in Total Knee Arthroplasty
- Where
- 34 sites in United States, Australia and 8 more
- Volunteers
- 400 people
- Sponsor
- DePuy Orthopaedics
Osteoarthritis, Arthritis
Bipolar Sealer Aquamantys Use in Total Knee Replacement
This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery.
- Conditions
- Osteoarthritis, Arthritis, Surgery, Infection
- Trial name
- NCT01736644
- Testing
- Electrocautery, Bipolar sealer Aquamantys
- Where
- 2 sites in United Kingdom
- Volunteers
- 97 people
- Sponsor
- Medtronic Surgical Technologies
Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery.
- Trial name
- NCT02491281
- Testing
- LNA043
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
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.
Knee Arthroplasty, Total, Robotic Surgical Procedures
ROSA® Knee System V1.5 Pilot Study
This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed. The primary objectives will be assessed by measuring: 1.
- Conditions
- Knee Arthroplasty, Total, Robotic Surgical Procedures, Joint Diseases, Knee Osteoarthritis
- Trial name
- NCT07009912
- Testing
- Total Knee Arthroplasty
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Knee Arthroplasty, Total
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
- Trial name
- FOXTROT (NCT03276143)
- Testing
- Enoxaparin, Apixaban, BAY1213790
- Where
- 54 sites in Bulgaria, Canada and 11 more
- Volunteers
- 813 people
- Sponsor
- Bayer
Osteoarthritis, Total Knee Arthroplasty
Use of Cold and Compression Therapy With Total Knee Replacement Patients
The purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.
- Trial name
- NCT00712816
- Testing
- Game Ready Injury Treatment System (CoolSystems Inc.), Ice with compressive bandages
- Where
- 11 sites in United States, Australia
- Volunteers
- 224 people
- Sponsor
- CoolSystems, Inc.
Degenerative Osteoarthritis, Rheumatoid Arthritis
VEGA Prospective Kiel
Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation.
- Trial name
- NCT02802085
- Testing
- VEGA Knee
- Where
- Germany
- Volunteers
- 84 people
- Sponsor
- Aesculap AG
Venous Thromboembolism
A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA
This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and…
- Trial name
- NCT07140523
- Testing
- SRSD107, enoxaparin
- Where
- Czechia
- Volunteers
- 450 people
- Sponsor
- Sirius Therapeutics Co., Ltd.
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
Prosthetic Joint Infection
Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA).
- Trial name
- NCT04294862
- Testing
- TNP-2092
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- TenNor Therapeutics Limited
Osteo Arthritis Knee, Knee Arthritis
Persona IQ Cohort Study
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative…
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty
- Trial name
- NCT06089291
- Testing
- Persona IQ
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Arthroplasty, Replacement, Knee, Thromboembolism
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared…
- Trial name
- NCT00152971
- Testing
- Dabigatran Dose 1 - day 2 to completion, Dabigatran Dose 1 - day 1, Dabigatran Dose 2 - day 2 to completion
- Where
- 94 sites in United States, Canada and 2 more
- Volunteers
- 2,615 people
- Sponsor
- Boehringer Ingelheim
Osteoarthritis
Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA).
- Trial name
- 10004 (NCT01746524)
- Testing
- ATTUNE Primary Total Knee Arthroplasty
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 1,138 people
- Sponsor
- DePuy Orthopaedics