Clinical trials: Arthroplasty; Replacement; Knee
Postsurgical Pain
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis.
- Trial name
- MP-TKA (NCT06202989)
- Testing
- Multiprofen-CC™ plus standard treatment
- Where
- Canada
- Volunteers
- 306 people
- Sponsor
- KAZM Pharmaceuticals Inc.
Knee Osteoarthritis, Post-traumatic Osteoarthritis
Clinical Evaluation of Vanguard DD RP
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the…
- Conditions
- Knee Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis
- Trial name
- NCT04076202
- Testing
- Cementless Vanguard DD RP
- Where
- Austria
- Volunteers
- 113 people
- Sponsor
- Zimmer Biomet
Total Knee Arthroplasty (Postoperative Pain)
Phase 2B Study Assessing Pain Relief After Replacement of the Knee
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty.
- Trial name
- SPARK2 (NCT06799845)
- Testing
- ATX101, bupivacaine hydrochloride
- Where
- 11 sites in United States
- Volunteers
- 226 people
- Sponsor
- Allay Therapeutics, Inc.
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
Degenerative Joint Disease, Osteoarthritis
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse…
- Trial name
- PRECISE (NCT01081886)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Surgical Technologies
Venous Thromboembolism
A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement (TKR) surgery.
- Trial name
- ROXI-VTE II (NCT06454630)
- Testing
- REGN7508, Enoxaparin
- Where
- 14 sites in Bulgaria, Hungary and 3 more
- Volunteers
- 179 people
- Sponsor
- Regeneron Pharmaceuticals
Bone Marrow Edema, Knee Pain Chronic
Subchondroplasty® Knee RCT
This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
- Conditions
- Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee
- Trial name
- PRESERVE Knee (NCT03112200)
- Testing
- Subchondroplasty with Arthroscopy, Arthroscopy Alone
- Where
- 13 sites in United States, Canada
- Volunteers
- 131 people
- Sponsor
- Zimmer Biomet
Analgesia
Safety of F14 Following Total Knee Replacement
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
- Trial name
- NCT04860635
- Testing
- F14 (sustained release celecoxib)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Arthritis Innovation Corporation
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
Osteoarthritis, Traumatic Arthritis
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus
- Trial name
- NCT00854295
- Testing
- NexGen LPS-Flex Mobile Bearing Knee
- Where
- 3 sites in United States
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Pain, Postoperative
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores
This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing…
- Trial name
- NCT03797612
- Testing
- Brivoligide Injection 660 mg/6 mL
- Where
- 2 sites in United States
- Sponsor
- Adynxx, Inc.
Arthroplasties, Knee Replacement, Revision Arthroplasty
Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow…
- Trial name
- NCT06203756
- Testing
- Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
- Where
- 6 sites in United States
- Volunteers
- 713 people
- Sponsor
- Corin
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
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
Surgical Robotics, Knee Replacement
A Retrospective Study of the Navio Robotic-assisted Surgical System
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
- Trial name
- NAVIO (NCT03072459)
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Smith & Nephew, Inc.
Knee Osteoarthritis
Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Knee Primary Osteoarthritis Who Are Candidates for Total Knee Replacement
Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those that are weight bearing such as the knees.
- Trial name
- NCT00911469
- Testing
- AS902330
- Where
- 19 sites in Bulgaria, Denmark and 4 more
- Volunteers
- 73 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Degenerative Osteoarthritis, Rheumatoid Arthritis
Orthopilot Elite Post-Market Clinical Follow-Up
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Instability, Joint
- Trial name
- NCT03817632
- Testing
- Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1, Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
- Where
- 3 sites in Germany
- Volunteers
- 217 people
- Sponsor
- Aesculap AG
Osteoarthritis, Knee
Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation
The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA).
- Trial name
- VISHE13 (NCT02158819)
- Testing
- Total knee arthroplasty with Visionaire
- Where
- 5 sites in South Africa
- Volunteers
- 52 people
- Sponsor
- Smith & Nephew, 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
Linear or Emi-linear Incisions, Total Hip Arthroplasty
Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
- Conditions
- Linear or Emi-linear Incisions, Total Hip Arthroplasty, Total Knee Arthroplasty
- Trial name
- Prevena2009-45 (NCT01380665)
- Testing
- Prevena Incisional Management System
- Sponsor
- KCI USA, Inc