Clinical trials: Arthroplasty of Knee
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
Bicompartmental Osteoarthritis
Study of the ConforMIS iDuo(R) G2
To evaluate the ConforMIS iDuo G2 implant
- Trial name
- NCT01564641
- Testing
- iDuo G2
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- Restor3D
Pain
A Study to Characterize Diclofenac's Plasma and Knee Exposure After Application of Diclofenac Gel to the Knee of Subjects With Osteoarthritis That Have a Scheduled Arthroplasty
The purpose of this study is to evaluate the exposure of diclofenac in the plasma and in the knee joint following topical administration of DDEA gel 4 gram (g) applied twice daily for 7 days.
- Trial name
- NCT03497039
- Testing
- Diclofenac Diethylamine (DDEA) gel
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Arthroplasty, Knee Replacement, Wound Healing
Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
- Trial name
- NCT02460172
- Testing
- Zip Surgical Skin Closure, Steel Staples
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.
Osteoarthritis, Post-traumatic Arthritis
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable…
- Trial name
- SOLO (NCT02574312)
- Testing
- ATTUNE TKA with ATTUNE RUI, ATTUNE TKA with ATTUNE SUI
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 88 people
- Sponsor
- DePuy Orthopaedics
Arthritis Knee, Aseptic Loosening
Retrospective Simplex High Viscosity (HV) Bone Cement Study
This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
- Trial name
- NCT05659329
- Testing
- Simplex HV/Gentamicin Simplex HV bone cement
- Volunteers
- 200 people
- Sponsor
- Stryker Orthopaedics
Venous Thrombosis, Pulmonary Embolism
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.
- Trial name
- NCT00097357
- Testing
- Apixaban, Enoxaparin, Warfarin
- Where
- 147 sites in United States, Argentina and 7 more
- Volunteers
- 1,238 people
- Sponsor
- Bristol-Myers Squibb
Total Knee Replacement Revision
LEGION™ Revision Metal Hypersensitivity Study
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
- Trial name
- NCT02412813
- Testing
- LEGION OXINIUM, LEGION Cobalt Chrome
- Where
- 3 sites in United States, Canada
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Knee
Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.
- Trial name
- VALALGON (NCT04912908)
- Testing
- Images taken during knee replacement surgery
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Ganymed Robotics
Osteoarthritis
Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville…
- Trial name
- NCT02962362
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Exactech
Osteoarthritis
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years…
- Trial name
- NCT02912351
- Testing
- Patient record review, Radiographs, and questionaires.
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Neuromuscular Blockade, Arthroplasty, Replacement, Hip
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on…
- Conditions
- Neuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation
- Trial name
- NCT01422304
- Testing
- Sugammadex, neostigmine and glycopyrrolate or atropine
- Volunteers
- 1,198 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Arthroplasties, Replacement, Knee
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A
This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.
- Trial name
- NCT02516163
- Testing
- Shapematch Cutting Guides
- Volunteers
- 55 people
- Sponsor
- Stryker South Pacific
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
Thromboembolism
SALTO - Epidemiological Study on Compliance and Treatment Satisfaction
Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks.
- Trial name
- SALTO (NCT00911001)
- Testing
- No Drug
- Where
- Spain
- Volunteers
- 480 people
- Sponsor
- Bayer
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.
Knee Disease
Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when…
- Trial name
- NCT04221581
- Testing
- Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis
- Where
- 3 sites in France
- Volunteers
- 43 people
- Sponsor
- FH ORTHO
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, Knee
Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement.
- Trial name
- NCT01108237
- Testing
- TruMatch™ Personalized Solutions, Total Knee Arthroplasty with Conventional Instrumentation.
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- DePuy Orthopaedics