Clinical trials: Total Joint Arthroplasty
Arthroplasty, Replacement
Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
Background: The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM) The JOURNEY II CR Total Knee System (JOURNEY II Cruciate…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- JIICRBCSTKA (NCT04822259)
- Testing
- JOURNEY II BCS Total Knee System, JOURNEY II CR Total Knee System
- Where
- 5 sites in China, India and 1 more
- Sponsor
- Smith & Nephew, Inc.
Osteo Arthritis Knee, Knee Arthritis
Persona IQ Cohort Study
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative…
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty
- Trial name
- NCT06089291
- Testing
- Persona IQ
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Total Knee Arthroplasty
A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus constraint is needed.
- Trial name
- NCT06578897
- Testing
- 3D Metal Tibial and Femoral cones
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Medacta International SA
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.
Osteoarthritis, Arthritis
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head
- Trial name
- NCT02196818
- Testing
- Mpact Acetabular Shell
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Total Hip Arthroplasty (THA)
A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
This is a prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral…
- Trial name
- NCT03646513
- Testing
- SMF Short Modular Femoral Hip System
- Where
- Australia
- Volunteers
- 4 people
- Sponsor
- Smith & Nephew, Inc.
Elbow Joint Destruction, Post-traumatic Lesions
Clinical Outcomes Study of the Nexel Total Elbow
The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.
- Conditions
- Elbow Joint Destruction, Post-traumatic Lesions, Ankylosed Joints, Advanced Rheumatoid Arthritis
- Trial name
- NCT02469662
- Testing
- Nexel Total Elbow
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 134 people
- Sponsor
- Zimmer Biomet
Arthritis of the Knee
Unity Total Knee Replacement Using Two Different Surgical Techniques
This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System.
- Trial name
- NCT02145455
- Testing
- Unity Total Knee Replacement System
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Corin
Severe Knee Pain, Severe Knee Disability
Zimmer POLAR Persona - TKA (EMEA Study)
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include: 1.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Osteoarthritis, Rheumatoid Arthritis
- Trial name
- NCT02337244
- Testing
- Zimmer Persona Total Knee System
- Where
- 12 sites in Austria, France and 4 more
- Volunteers
- 777 people
- Sponsor
- Zimmer, GmbH
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
Knee Osteoarthritis, Knee Pain Chronic
Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and…
- Trial name
- KA vs MA (NCT05461638)
- Testing
- Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides, Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medacta USA
Arthritis, Infection of Total Ankle Joint Prosthesis
INBONE™ Total Ankle Prosthesis With Long Talar Stem
The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.
- Trial name
- NCT01641848
- Testing
- INBONE™ Total Ankle Prosthesis with Long Talar Stem
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stryker Trauma and Extremities
Total Knee Arthroplasty
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）
This is a randomized, double-blind, active-controlled, multicenter, phase II clinical study designed to evaluate the efficacy and safety of BT-114143 Injection in the perioperative treatment of unilateral total knee arthroplasty.
- Trial name
- TKA (NCT07127042)
- Testing
- Low-dose BT-114143, High-dose BT-14143, Tranexamic Acid (IV)
- Where
- China
- Volunteers
- 270 people
- Sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03726554
- Testing
- Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Zimmer Biomet
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.