Clinical trials: Open Fracture
Long Bone Delayed-Union Fracture
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone.
- Trial name
- NCT02020590
- Testing
- ALLOB® implantation
- Volunteers
- 25 people
- Sponsor
- Bone Therapeutics S.A
Tibia Fractures
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D…
- Trial name
- NCT01282294
- Testing
- ETN PROtect
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Synthes GmbH
Breast Cancer, Osteoporosis
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
- Trial name
- NCT00767585
- Where
- Slovenia
- Volunteers
- 560 people
- Sponsor
- AstraZeneca
Postmenopausal Osteoporosis
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
- Trial name
- NCT06079476
- Testing
- Romosozumab
- Where
- 10 sites in India
- Volunteers
- 100 people
- Sponsor
- Amgen
Venous Thromboembolism
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
- Trial name
- NCT01181141
- Testing
- DU-176b (edoxaban), Enoxaparin sodium 20mg
- Where
- Japan
- Volunteers
- 92 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Non Union Fracture, Non-Union of Ankle Joint Without Infection
Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
The study is aimed to compare the effectiveness of "Histograft" bone substitute (gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) mixed with shredded autobone and pure shredded…
- Trial name
- NCT04705857
- Testing
- "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- Histograft Co., Ltd.
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Tibia Plateau Fractures
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the…
- Trial name
- NCT00409799
- Testing
- I-0401 (a new bone graft substitute)
- Where
- 45 sites in Australia, France and 7 more
- Volunteers
- 208 people
- Sponsor
- Kuros Biosurgery AG
Trauma
Adjunctive Therapy to Treat Tibial Shaft Fractures
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups…
- Trial name
- TSF (NCT00533793)
- Testing
- open fracture reduction
- Where
- 49 sites in Bulgaria, Czechia and 10 more
- Volunteers
- 201 people
- Sponsor
- Kuros Biosurgery AG
Long Bone Non-Union
Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003).
- Trial name
- NCT01756326
- Testing
- PREOB® Implantation, Bone Autograft
- Where
- 16 sites in Belgium, France and 1 more
- Volunteers
- 5 people
- Sponsor
- Bone Therapeutics S.A
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.
Osteoporosis, Postmenopausal
Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women
This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China.
- Trial name
- NCT03158246
- Testing
- Generic Zoledronic Acid, Original Zoledronic Acid, calcium
- Volunteers
- 466 people
- Sponsor
- Cttq
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.
Postmenopausal Women With Osteoporosis
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.
- Trial name
- NCT06898060
- Testing
- QLG2128, Teriparatide Injection
- Volunteers
- 282 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Venous Thromboembolism
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.
- Trial name
- NCT00937911
- Testing
- YM150
- Where
- 8 sites in Japan
- Volunteers
- 101 people
- Sponsor
- Astellas Pharma Inc
Aseptic Loosening, Osteolysis
Post-Market Study of the Modular Revision Hip System
The purpose of this study is to examine the short term efficacy of the MRH system as well as determine if operating room time is decreased using this simple, two-tray system.
- Conditions
- Aseptic Loosening, Osteolysis, Traumatic Fracture, Failed Total Hip Implant
- Trial name
- MRHS (NCT01464645)
- Testing
- Modular Revision Hip System
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Encore Medical, L.P.
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
Osteogenesis Imperfecta
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI).
- Trial name
- NCT01417091
- Testing
- BPS804
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Articular Cartilage Defect
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the…
- Trial name
- SUMMIT (NCT00719576)
- Testing
- autologous cultured chondrocytes on porcine collagen membrane, Microfracture
- Where
- 20 sites in Czechia, France and 5 more
- Volunteers
- 144 people
- Sponsor
- Vericel Corporation
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.