Clinical trials: Lower Extremity Fractures
Femur Fracture, Osteotomy
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical…
- Trial name
- NCT05339360
- Testing
- Femoral fixation with intramedullary nails
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Hip Fracture
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following…
- Trial name
- SHIFT (NCT00787358)
- Testing
- ZT-031
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Zelos Therapeutics
Bimalleolar Ankle Fractures
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization.
- Trial name
- NCT02688855
- Testing
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Where
- 9 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.
Delirium
Hip Fracture Surgery in Elderly Patients
The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with…
- Trial name
- HIPELD (NCT01199276)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in Belgium, France and 4 more
- Volunteers
- 256 people
- Sponsor
- Air Liquide Santé International
Hip Fractures, Subtrochanteric Fractures
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body.
- Conditions
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures, Pertrochanteric Fracture
- Trial name
- Chimaera (NCT05197335)
- Testing
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws
- Where
- 8 sites in Italy
- Volunteers
- 206 people
- Sponsor
- Orthofix s.r.l.
Ankle Fractures, Knee Fractures
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of…
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Trial name
- NCT07473947
- Testing
- Fracture fixation operation
- Where
- Finland
- Volunteers
- 80 people
- Sponsor
- Inion Oy
Femoral Fracture
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled.
- Trial name
- NCT04015128
- Testing
- Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Where
- 6 sites in United States
- Volunteers
- 66 people
- Sponsor
- Stryker Trauma and Extremities
Femur Fractures
The CHINA TFNA Study
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally.
- Trial name
- TFNA (NCT03635320)
- Testing
- TFNA, PFNA-II
- Where
- 9 sites in China
- Volunteers
- 188 people
- Sponsor
- Synthes GmbH
Tibial Fractures
Multiregion BHA in Open Tibia Fractures
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open…
- Trial name
- NCT04056429
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Fractures, Bone, Nonunion of Fracture
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union…
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited
- Trial name
- NCT04299022
- Testing
- Vivigen Cellular Bone Matrix
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- LifeNet Health
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, Inc.
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Hip Fractures, Osteoporosis, Postmenopausal
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
- Trial name
- NCT03268356
- Testing
- AGN1 Femoral Local Osteo-Enhancement Procedure Kit
- Where
- Hong Kong
- Volunteers
- 13 people
- Sponsor
- AgNovos Healthcare, LLC
Femoral Neck Fractures
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.
- Trial name
- NCT00757653
- Testing
- Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA, Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA, Hip stem with Interloc Titanium surface + Bonemaster H.A
- Where
- United Kingdom
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Tibial Fracture, Femoral Fracture
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed…
- Conditions
- Tibial Fracture, Femoral Fracture, Humeral Fracture
- Trial name
- NCT07569575
- Testing
- Magnesium-Titanium Hybrid Intramedullary Nail System, Commercially Locked Metallic Intramedullary Nail
- Where
- 5 sites in China
- Volunteers
- 160 people
- Sponsor
- HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Bone Fracture, Tibia Fracture
Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
- Conditions
- Bone Fracture, Tibia Fracture, Femur Fracture
- Trial name
- NCT07518836
- Testing
- femur or tibia fracture, SurgiFill™
- Where
- 3 sites in South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Osteoporosis
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study.
- Trial name
- NCT05202678
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- AgNovos Healthcare, LLC
Tibial Fractures, Fracture Infection
Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.
- Trial name
- NCT05022485
- Testing
- ZNN Bactiguard tibia
- Where
- 16 sites in Austria, France and 6 more
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet