Clinical trials: Arthroplasty of Knee
Circulatory Disease
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
This study is a multicenter, randomized, open-label, positive-controlled Phase II clinical study to evaluate the efficacy and safety of H001 capsules in the prevention of venous thromboembolism (VTE) in subjects undergoing Total…
- Trial name
- NCT06963320
- Testing
- H001 Capsule 200mg-qd, Enoxaparin Sodium Injection, H001 Capsule 300mg-qd
- Where
- China
- Volunteers
- 320 people
- Sponsor
- Livzon Pharmaceutical Group Inc.
Arthroplasty, Replacement, Knee
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.
- Trial name
- ScorpioNRGPS (NCT02520531)
- Testing
- Scorpio PS (posterior stable), Scorpio NRG PS
- Where
- Netherlands
- Volunteers
- 84 people
- Sponsor
- Stryker Orthopaedics
Osteoarthritis
Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study
To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a…
- Trial name
- NCT02583113
- Testing
- Total and Unicompartment Knee Replacement
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medacta USA
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.
Knee Osteoarthristis, Total Knee Anthroplasty
Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
- Trial name
- NCT06627699
- Testing
- Total Knee Arthroplasty
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Maxx Orthopedics Inc
Postoperative Pain
Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty
This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
- Trial name
- NCT00818493
- Testing
- Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride), Percocet (oxycodone and acetaminophen)
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- QRxPharma Inc.
Osteoarthritis
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee joint.
- Trial name
- NCT00454298
- Testing
- AGG-523 (Aggrecanase Inhibitor)
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Knee Arthroplasty
Zip Arthroplasty Patient Satisfaction Evaluation
This study is a prospective, randomized, single center, study to evaluate Zip Closure Device in subjects undergoing knee arthroplasty.
- Trial name
- ZAPS (NCT03178266)
- Testing
- Knee Arthroplasty
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.
Pain, Postoperative
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.
- Trial name
- NCT03434275
- Testing
- N1539
- Where
- 6 sites in United States
- Volunteers
- 194 people
- Sponsor
- Baudax Bio
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
Osteoarthritis, Knee
A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
- Trial name
- NCT03073941
- Testing
- Persona total knee system, Nexgen total knee system
- Where
- 5 sites in Denmark
- Volunteers
- 332 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Knee, Osteoarthritis, Hip
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo…
- Trial name
- NCT03949673
- Testing
- Fasinumab, Naproxen, Diclofenac
- Where
- 15 sites in United States, Poland and 1 more
- Volunteers
- 23 people
- Sponsor
- Regeneron Pharmaceuticals
Venous Thromboembolism
An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study
The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells).
- Trial name
- NCT00402467
- Testing
- Rivaroxaban (BAY59-7939), Rivaroxaban, (BAY59-7939), Enoxaparine
- Where
- 36 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Bayer
Postsurgical Pain
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.
- Trial name
- NCT03731364
- Testing
- CA-008
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Concentric Analgesics
Knee Arthropathy
Persona Cohort Nordic Multicenter Study
In this project the investigators wish to: Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total…
- Trial name
- NCT03495232
- Testing
- Zimmer Biomet Persona total knee system
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 700 people
- Sponsor
- Zimmer Biomet
Total Knee Replacement
Long Term Foundation Knee Study
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.
- Trial name
- NCT01274546
- Testing
- cruciate-retaining Foundation Knee system
- Where
- 2 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
Venous Thromboembolism
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d.
- Trial name
- NCT01225822
- Testing
- Enoxaparin, BIBR 1048
- Where
- 59 sites in Austria, Belgium and 10 more
- Volunteers
- 1,973 people
- Sponsor
- Boehringer Ingelheim
Complications; Arthroplasty
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal…
- Trial name
- NCT01882751
- Testing
- Conformis CR Total Knee Replacement, Off the Shelf
- Where
- 2 sites in United States
- Volunteers
- 66 people
- Sponsor
- Restor3D
Osteoarthritis, Pain
Celebrex Total Knee Arthroplasty Study
This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee…
- Trial name
- NCT00359151
- Testing
- Celecoxib
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Osteoarthritis
A Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement Using Stryker's Mako Robot
This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement.
- Trial name
- NCT04600583
- Testing
- Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)
- Where
- New Zealand
- Volunteers
- 278 people
- Sponsor
- Stryker South Pacific