Clinical trials: Fractures, Bone
Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis
Tornier Perform™ Reversed Monopost Study
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis, Correction of Functional Deformity, Fracture of the Humeral Head
- Trial name
- Monarch (NCT07764614)
- Testing
- Tornier Perform™ Reversed MonoPost
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Stryker Trauma and Extremities
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.
Primary Osteoarthritis, Secondary Osteoarthritis
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
This is a post-marketing surveillance on MiniMAX Stem
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT06012656
- Testing
- MiniMAX
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Medacta International SA
Orthopedic Disorder, Trauma Injury
X-BS Ortho Bone Graft Study
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
- Conditions
- Orthopedic Disorder, Trauma Injury, Extremity Injury
- Trial name
- NCT06326827
- Testing
- FDBS (GraftR3®), IBS (MBCP® Putty)
- Volunteers
- 200 people
- Sponsor
- Advanced Medical Solutions Ltd.
Healthy, Osteopenia
Clinical Study to Estimate Bone Mineral Density 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-BMD (NCT07187518)
- Testing
- Measurements with the POROUS R4C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine
- Where
- 2 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Osteo Arthritis Shoulders, Osteonecrosis
Exactech Shoulder Post Market Clinical Follow-up Study
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time.
- Conditions
- Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Trial name
- NCT05603728
- Where
- 40 sites in United States, Canada and 4 more
- Volunteers
- 20,000 people
- Sponsor
- Exactech
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
Duchenne Muscular Dystrophy
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory…
- Trial name
- SHIELD DMD (NCT06450639)
- Testing
- Satralizumab
- Where
- 18 sites in United States, Denmark and 4 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Osteoarthritis (OA) of the Knee, Fracture
LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing…
- Conditions
- Osteoarthritis (OA) of the Knee, Fracture, Rheumatoid Arthritis
- Trial name
- NCT06670651
- Testing
- total knee arthroplasty device
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- LinkBio Corp.
Traumatic Arthropathy of Shoulder, Fracture Humerus
Perform® Humeral System - Fracture Study (PFX)
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available…
- Conditions
- Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains
- Trial name
- PFX (NCT05773352)
- Testing
- Tornier Perform® Humeral System - Fracture
- Where
- 9 sites in United States
- Volunteers
- 118 people
- Sponsor
- Stryker Trauma and Extremities
Osteoporosis, Osteoarthritis
OSTEOMICS: Identifying Regulators of Bone Homeostasis
Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity.
- Conditions
- Osteoporosis, Osteoarthritis, Bone Diseases, Bone Fracture
- Trial name
- OSTEOMICS (NCT05732870)
- Testing
- Relevant orthopaedic surgery
- Where
- 8 sites in United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Relation Therapeutics
Bone Tumor, Osteoporosis
U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.
- Conditions
- Bone Tumor, Osteoporosis, Traumatic Fracture
- Trial name
- EPIOS (NCT07325578)
- Testing
- Percutaneous procedure in the MSK structures of the pelvis and/or the spine
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Precision IO Group
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
Fractures, Bone, Fracture Multiple
MDR - Biomet Cannulated Screws
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when…
- Trial name
- NCT04002518
- Testing
- Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Zimmer Biomet
Fractures of the Long Bones, Vertically Stable Pelvic Fractures
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice.
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Trial name
- NCT06690437
- Testing
- Galaxy Fixation System and Orthofix implantable devices
- Where
- 3 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Orthofix s.r.l.
Vertebral Compression Fracture
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults.
- Trial name
- EXPAND (NCT07301749)
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 3 sites in France, Germany
- Volunteers
- 148 people
- Sponsor
- Amber Implants B.V.
Vertebral Compression Fracture
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and…
- Trial name
- NCT07259811
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Amber Implants B.V.
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
Sport Medicine
ATI Evidence-based Guide Investigating Medical and Preventative Services
To use existing standard-of-care documentation in a sports medicine electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine sports…
- Trial name
- NCT04050319
- Testing
- Screening and diagnosis if injured
- Where
- United States
- Volunteers
- 550,000 people, healthy volunteers welcome
- Sponsor
- ATI Holdings, LLC
Femoral Fracture
Post Market Clinical Evaluation of Gamma 4
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment.
- Trial name
- PEGASUS (NCT05523635)
- Testing
- Gamma4 Nailing System
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities