Clinical trials: TKA
Knee Replacement Surgery, Osteoarthritis
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
- Trial name
- NCT01410240
- Testing
- Standard of Care, FLOSEAL Hemostatic Matrix + Standard of care
- Where
- 12 sites in United States
- Volunteers
- 137 people
- Sponsor
- Baxter Healthcare Corporation
Knee Osteoarthritis
Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA
The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1…
- Trial name
- NCT02034032
- Testing
- Regenexx SD, Exercise Therapy
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Regenexx, LLC
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
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.
Total Knee Arthroplasty
PMCF Study of MPS-Flex® Knee System in TKA
The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee arthroplasty (TKA).
- Trial name
- NCT04427722
- Testing
- MPS-Flex Total Knee Joint Prostheses
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Zimmer Biomet
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
Knee Osteoarthritis, Knee Arthritis
ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)
ROMTech is focused on transforming the healthcare market by delivering lower extremity rehabilitation systems that are effective, efficient for patient use, cost-effective, and provide better patient outcomes while simultaneously…
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic, Knee Disease
- Trial name
- NCT04497129
- Testing
- ROMTech PortableConnect, Traditional Rehabilitation and CPM Device
- Where
- 5 sites in United States
- Volunteers
- 300 people
- Sponsor
- ROM Technologies, INC
Joint Infection
Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for…
- Trial name
- NCT05137314
- Testing
- PLG0206
- Where
- 12 sites in United States
- Volunteers
- 14 people
- Sponsor
- Peptilogics
Arthroplasty, Replacement
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04849884
- Testing
- CORI™ KNEE TENSIONER
- Where
- 4 sites in United States
- Volunteers
- 77 people
- Sponsor
- Smith & Nephew, Inc.
Postoperative Pain
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative…
- Trial name
- NCT00403234
- Testing
- Buprenorphine transdermal patch
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Purdue Pharma LP
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.
Knee Osteoarthritis
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured…
- Trial name
- NCT06627673
- Testing
- Total Knee Arthroplasty
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Maxx Orthopedics 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.
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.
Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
- Trial name
- NCT07091773
- Testing
- OLIZ Photobiomodulation Device
- Volunteers
- 68 people
- Sponsor
- LTBIO Co., Ltd.
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
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.
Knee Osteoarthritis, Pain Management
Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral…
- Trial name
- NCT05139030
- Testing
- bupivacaine liposome injectable suspension, Bupivacaine Hydrochloride
- Where
- 6 sites in United States
- Volunteers
- 167 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Osteoarthritis
10003 PRO Current Products
This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA).
- Trial name
- 10003 (NCT01497730)
- Testing
- Total Knee Replacement
- Where
- 22 sites in United States, Australia and 2 more
- Volunteers
- 842 people
- Sponsor
- DePuy Orthopaedics
Venous Thromboembolism
A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants
The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin The secondary objectives of the…
- Trial name
- NCT05618808
- Testing
- REGN9933, Enoxaparin, Apixiban
- Where
- 16 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 373 people
- Sponsor
- Regeneron Pharmaceuticals