Clinical trials: TKA
Infection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee…
- Trial name
- NCT02266407
- Testing
- Aquamantys System
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
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
Total Knee Arthroplasty
Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA
This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA).
- Trial name
- NCT02922582
- Testing
- DepoTXA, Tranexamic Acid
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Pacira Pharmaceuticals, 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
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
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
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
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
Osteoarthritis, Rheumatoid Arthritis
Scorpio Non Restricted Geometry (NRG) Study in Japan
The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device.
- Trial name
- NCT02552082
- Testing
- Scorpio NRG posterior stabilized (PS)
- Where
- Japan
- Volunteers
- 150 people
- Sponsor
- Stryker Japan K.K.
Total Knee Replacement
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.
- Trial name
- NCT01548040
- Testing
- Kneehab XP, Quadriceps TENS
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Theragen Inc.
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
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
Osteoarthritis, Rheumatoid Arthritis
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Rheumatoid Arthritis
- Trial name
- NCT00289094
- Testing
- Total Knee Replacement
- Where
- 2 sites in United States
- Volunteers
- 99 people
- Sponsor
- DePuy Orthopaedics
Pain, Postoperative
A Phase I Dose-escalation Study of a Single Administration of Extended-Release Injectable Suspension (ND-340)
This study focused on ND-340 extended release injection suspension for patients undergoing total knee arthroplasty with a one-time nerve blockade to assess drug side effects, pharmacokinetics and the effect of pain relief after…
- Trial name
- NCT04515953
- Testing
- ND-340, IV-PCA
- Where
- Taiwan
- Volunteers
- 36 people
- Sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
Osteoarthritis, Knee
Study of the KinexConnect Telerehabilitation System (KCTRS)
A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT)…
- Trial name
- KCTRS (NCT04191798)
- Testing
- Telerehabilitation using the KinexConnect system for rehabilitation after TKA., Traditional outpatient PT for rehabilitation after TKA.
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kinex Medical Company, LLC
Osteoarthritis, Knee, Knee Osteoarthritis
A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS
This study is designed to evaluate implant survivorship, patient satisfaction, and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal®…
- Trial name
- NCT03152357
- Testing
- ConforMIS iUni, iDuo, or iTotal (CR)
- Where
- United States
- Volunteers
- 950 people
- Sponsor
- Restor3D
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.
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 proof of concept study are to evaluate the safety and preventive analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee…
- Trial name
- NCT01731730
- Testing
- AYX1 Injection 110 mg, AYX1 Injection 330 mg
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Adynxx, Inc.
Osteoarthritis, Knee, Joint Diseases
Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance.
- Conditions
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
- Trial name
- TKA4U (NCT06955481)
- Testing
- Navigated Total Knee Arthroplasty
- Where
- 4 sites in Czechia, Germany
- Volunteers
- 120 people
- Sponsor
- Aesculap AG
Analgesia
Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
- Trial name
- NCT03974932
- Testing
- HTX-011, Ibuprofen, Acetaminophen
- Where
- 6 sites in United States
- Volunteers
- 116 people
- Sponsor
- Heron Therapeutics