Clinical trials: Fractures, Bone
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
Subchondral Cysts, Subchondral Bone Edema
SCP Hip Outcomes Study
Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting.
- Conditions
- Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema, Insufficiency Fractures
- Trial name
- NCT03494660
- Testing
- Subchondroplasty Procedure with AccuFill
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- Zimmer Biomet
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.
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.
Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip
MDR Vivacit-E Elevated Study
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
- Conditions
- Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli, Traumatic Arthropathy-Hip
- Trial name
- NCT07150221
- Testing
- Vivacit-E Elevated Liners
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
Fractures, Musculoskeletal
Enhancing Diagnostic Accuracy in Fracture Identification on Musculoskeletal Radiographs Using Deep Learning
This retrospective study aims to evaluate the effectiveness of artificial intelligence (AI) in identifying fractures on musculoskeletal X-rays.
- Trial name
- NCT06644391
- Testing
- Carebot AI Bones
- Where
- Czechia
- Volunteers
- 600 people
- Sponsor
- Carebot s.r.o.
Osteoarthritis of the Shoulder
TITAN™ Reverse Shoulder System
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the…
- Trial name
- NCT02204228
- Testing
- TITAN™ Reverse Shoulder System (TRS)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 151 people
- Sponsor
- Smith & Nephew, Inc.
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Fracture, Joint Dislocation
Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries
The goal of this study is to determine if the computer software, RBfracture, developed by Radiobotics, helps primary care, emergency, and radiology clinicians more easily identify bone injuries caused by a traumatic impact (such…
- Conditions
- Fracture, Joint Dislocation, Joint Effusion, Knee Lipohemarthrosis
- Trial name
- NCT07421791
- Testing
- RBfracture
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- Radiobotics
Hypoparathyroidism, Osteoporosis
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with modified oral formulations (EBP11, EBP11-F1, EBP11-F2, EBP11-F4, EBP11-F5 and EBP22) versus three dose levels of…
- Conditions
- Hypoparathyroidism, Osteoporosis, Fractures, Bone, Other Disease
- Trial name
- NCT05965167
- Testing
- EBP05, Forteo 0.02 mg, EBP11
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Entera Bio Ltd.
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Osteoporosis in Post-menopausal Women, Osteoporosis
Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
The primary objective of this study is to evaluate the safety and tolerability of human umbilical cord-derived mesenchymal stem cells for injection (HMM910 ) in postmenopausal women with osteoporosis who are at high risk of…
- Trial name
- NCT06949137
- Testing
- Human Umbilical Cord-derived Mesenchymal stem cell
- Where
- China
- Volunteers
- 9 people
- Sponsor
- HELP Therapeutics Co., Ltd.
Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders
FX Shoulder Prospective Clinical Study
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder
- Trial name
- NCT06078865
- Testing
- FX Artificial Shoulder Prosthesis
- Where
- 4 sites in United States
- Volunteers
- 600 people
- Sponsor
- FX Shoulder Solutions
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
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.
Bone Fractures
Opioid Management for Discharged Emergency Department Patients
The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid…
- Trial name
- NCT06592378
- Testing
- Addinex, Standard Pill Bottle
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Addinex Technologies, Inc.
Bone Fracture
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications: 1.
- Trial name
- NCT03024008
- Testing
- BonoFill-II
- Where
- 6 sites in Israel
- Volunteers
- 40 people
- Sponsor
- BonusBio Group Ltd
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT03547947
- Testing
- Medacta Shoulder System
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
This is a post-market surveillance study on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05002335
- Testing
- Medacta Shoulder System
- Where
- 3 sites in Belgium
- Volunteers
- 200 people
- Sponsor
- Medacta International SA