Clinical trials: Total Knee Replacements
Postoperative Pain
A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
- Trial name
- TKA (NCT00745290)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 19 sites in United States
- Volunteers
- 245 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
Arthritis Knee
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
- Trial name
- NCT05693818
- Testing
- Clinical Limping Evalution
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Canary Medical
Osteoarthritis
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.
- Trial name
- NCT02494544
- Testing
- Off the Shelf Total Knee Replacement, ConforMIS iTotal Knee Replacement
- Where
- 8 sites in United States
- Volunteers
- 215 people
- Sponsor
- Restor3D
Deep Vein Thrombosis, Fibrillation, Atrial
Odiparcil For The Prevention Of Venous Thromboembolism
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
- Conditions
- Deep Vein Thrombosis, Fibrillation, Atrial, Venous Thromboembolism, Pulmonary Embolism
- Trial name
- NCT00244725
- Testing
- Odiparcil, Warfarin, Coumadin
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 961 people
- Sponsor
- GlaxoSmithKline
Osteoarthritis, Rheumatoid Arthritis
Robotic Arm Assisted Total Knee Arthroplasty
The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- Trial name
- NCT02058069
- Testing
- Robotic Arm Assisted Total Knee Arthroplasty
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- MAKO Surgical Corp.
Pain
Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty
This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with…
- Trial name
- NCT02284386
- Testing
- Bupivacaine SNB, EXPAREL Infiltration
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Knee Pain Chronic, Rheumatoid Arthritis
Cemented vs Cementless Persona Keel RCT
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
- Conditions
- Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis
- Trial name
- NCT05630053
- Testing
- Cementless Persona Knee System, Cemented Persona Knee System
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zimmer Biomet
Total Knee Arthroplasty, Knee Disease
Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT05211141
- Testing
- HLS KneeTec Deep Dish
- Where
- France
- Volunteers
- 119 people
- Sponsor
- Corin
Total Knee Arthroplasty; Total Hip Arthroplasty
Health Partner Evaluation at Providence
This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health \& Services will enroll a total of 296 subjects (18 years or older) who are electing to have total knee or hip…
- Trial name
- NCT03443284
- Testing
- Health Partner, Standard Care
- Where
- 3 sites in United States
- Volunteers
- 79 people
- Sponsor
- DePuy Orthopaedics
Thromboembolism, Arthroplasty, Replacement, Hip
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
Open, prospective, uncontrolled, observational cohort study.
- Trial name
- NCT00967447
- Where
- 28 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Post-operation Pain
A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty
This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.
- Trial name
- NCT02263222
- Testing
- MDT-10013
- Where
- 3 sites in United States
- Sponsor
- Medtronic Spinal and Biologics
Post-surgical Pain
Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
- Trial name
- NCT02807428
- Testing
- AYX1 Injection 660 mg/6 mL
- Where
- 9 sites in United States
- Volunteers
- 210 people
- Sponsor
- Adynxx, 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
Knee Pain, Chronic Osteoarthritis
ROSA Robot Used in Total Knee Replacement Post Market Study
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data.
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities
- Trial name
- NCT03969654
- Testing
- PERSONA Total Knee, Vanguard Total Knee, NexGen Total Knee
- Where
- 5 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Postsurgical Pain
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.
- Trial name
- NCT02081703
- Testing
- AYX1 Injection 660 mg / 6 mL, AYX1 Injection 1100 mg / 10 mL
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Adynxx, Inc.
Osteo Arthritis Knee, Osteoarthritis
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual…
- Trial name
- NCT04730271
- Testing
- Total Knee Replacement
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- DePuy Orthopaedics
Osteoarthritis of the Knee
Total Knee Arthroplasty Functional Outcomes Study Research Design
The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.
- Trial name
- NCT02228538
- Testing
- Total knee arthroplasty patients
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Restor3D
Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement
Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36…
- Trial name
- NCT01010828
- Testing
- Incision technique
- Where
- Japan
- Volunteers
- 72 people
- Sponsor
- Zimmer Biomet
Wound Closure
Symmetric on Total Knee Arthroplasty (TKA)
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to…
- Trial name
- SFX (NCT03305887)
- Testing
- "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS, "STRATAFIX Spiral" sutures
- Where
- 7 sites in China
- Volunteers
- 184 people
- Sponsor
- Johnson & Johnson Medical, China