Clinical trials: Knee Replacement, Total
Arthroplasty, Replacement, Knee
ShapeMatch Cutting Guide Functional Outcomes Study
Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.
- Trial name
- ShapeMatch (NCT02539992)
- Testing
- Triathlon® CR/Kinematic Alignment, Triathlon® CR/Neutral Overall Limb Alignment, Triathlon® CR/Conventional Limb Alignment
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 44 people
- Sponsor
- Stryker Orthopaedics
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
Surgical Wound
A Post-Market Clinical Investigation on Mepilex Border Post-Op
This is a retrospective, observational (non-interventional), single-arm, single-centre, post-market clinical investigation designed to verify clinical performance and safety of Mepilex Border Post-Op when used according to…
- Trial name
- ARCTIS (NCT04994145)
- Where
- Belgium
- Volunteers
- 560 people
- Sponsor
- Molnlycke Health Care AB
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
- Trial name
- NCT00847301
- Where
- 53 sites in Austria, France and 5 more
- Volunteers
- 472 people
- Sponsor
- Boehringer Ingelheim
Knee Arthroplasty, Total
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System
- Trial name
- NCT05653102
- Testing
- Truliant Total Knee System
- Where
- 5 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Exactech
Postoperative Pain
A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
- Trial name
- TKA (NCT00745290)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 19 sites in United States
- Volunteers
- 245 people
- Sponsor
- Pacira Pharmaceuticals, 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
Arthritis Knee
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
- Trial name
- NCT05693818
- Testing
- Clinical Limping Evalution
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Canary Medical
Osteoarthritis
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.
- Trial name
- NCT02494544
- Testing
- Off the Shelf Total Knee Replacement, ConforMIS iTotal Knee Replacement
- Where
- 8 sites in United States
- Volunteers
- 215 people
- Sponsor
- Restor3D
Deep Vein Thrombosis, Fibrillation, Atrial
Odiparcil For The Prevention Of Venous Thromboembolism
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
- Conditions
- Deep Vein Thrombosis, Fibrillation, Atrial, Venous Thromboembolism, Pulmonary Embolism
- Trial name
- NCT00244725
- Testing
- Odiparcil, Warfarin, Coumadin
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 961 people
- Sponsor
- GlaxoSmithKline
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.
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
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
Total Knee Arthroplasty, Knee Disease
Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT05211141
- Testing
- HLS KneeTec Deep Dish
- Where
- France
- Volunteers
- 119 people
- Sponsor
- Corin
Total Knee Arthroplasty; Total Hip Arthroplasty
Health Partner Evaluation at Providence
This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health \& Services will enroll a total of 296 subjects (18 years or older) who are electing to have total knee or hip…
- Trial name
- NCT03443284
- Testing
- Health Partner, Standard Care
- Where
- 3 sites in United States
- Volunteers
- 79 people
- Sponsor
- DePuy Orthopaedics
Thromboembolism, Arthroplasty, Replacement, Hip
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
Open, prospective, uncontrolled, observational cohort study.
- Trial name
- NCT00967447
- Where
- 28 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Post-operation Pain
A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty
This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.
- Trial name
- NCT02263222
- Testing
- MDT-10013
- Where
- 3 sites in United States
- Sponsor
- Medtronic Spinal and Biologics
Post-surgical Pain
Study to Evaluate Safety/Efficacy of a Single Preop 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 in patients undergoing unilateral total knee arthroplasty.
- Trial name
- NCT02807428
- Testing
- AYX1 Injection 660 mg/6 mL
- Where
- 9 sites in United States
- Volunteers
- 210 people
- Sponsor
- Adynxx, 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
Knee Pain, Chronic Osteoarthritis
ROSA Robot Used in Total Knee Replacement Post Market Study
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data.
- Conditions
- Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities
- Trial name
- NCT03969654
- Testing
- PERSONA Total Knee, Vanguard Total Knee, NexGen Total Knee
- Where
- 5 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet