Clinical trials: Lower Limb Fracture
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.
Femoral Fracture
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also…
- Trial name
- SERRE (NCT05087667)
- Testing
- Implantation of Ortholoop cerclage, Implantation of Cerclage used in current practice
- Where
- 15 sites in France
- Volunteers
- 202 people
- Sponsor
- Quanta Medical
Fracture Femur, Fracture Tibia
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs.
- Trial name
- CETIULTRA-BONE (NCT07299851)
- Testing
- CFA-based food supplement
- Where
- 6 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Pharmanutra S.p.a.
Sacroiliitis, Sacroiliac Joint Dysfunction
Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
The purpose of this clinical study is to evaluate fusion of the SI joint(s) and any reduction in VAS pain scores in a prospective cohort of patients utilizing the SiJoin® Transfixing Sacroiliac Fusion Device in patients that…
- Conditions
- Sacroiliitis, Sacroiliac Joint Dysfunction, Iatrogenic Injury, Osteitis Condensans Ilii
- Trial name
- NCT05712850
- Testing
- SiJoin® Transfixing Sacroiliac Fusion Device
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- VG Innovations, LLC
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
Femoral Fracture
ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used…
- Trial name
- NCT05276674
- Testing
- ZNN Bactiguard Retrograde Femoral Nail
- Where
- 4 sites in Spain, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Hip, Rheumatoid Arthritis
Avenir Müller Hip Stem Post Market Surveillance Study
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip
- Trial name
- NCT04079127
- Testing
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Wrist Injury, Tibial Fracture
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Trial name
- TOMO (NCT01927575)
- Testing
- Standard X-Ray + CT, Standard X-Ray + MRI, TOMO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fujifilm Medical Systems USA, Inc.
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.
Proximal or Diaphyseal Humerus Fracture, Diaphyseal or Distal Femur Fracture
Observational Patient Registry of the Dynamic Locking Screws
The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS.
- Conditions
- Proximal or Diaphyseal Humerus Fracture, Diaphyseal or Distal Femur Fracture, Diaphyseal, Distal or Proximal Tibia Fracture
- Trial name
- DLS (NCT02656628)
- Testing
- Dynamic Locking Screw 3.7mm and 5.0mm
- Where
- Australia
- Sponsor
- Synthes GmbH
Fracture;Pelvis, Sacral Fracture
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture
- Trial name
- SAFFRON (NCT05426356)
- Testing
- Surgical Intervention, Non-Surgical Management
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- SI-BONE, Inc.
Fracture of Hip, Osteoporosis
Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side
HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal…
- Trial name
- NCT03648775
- Testing
- Y-STRUT® (Hyprevention, Pessac, France)
- Where
- 5 sites in France
- Volunteers
- 10 people
- Sponsor
- Hyprevention
Hip Fracture
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD intramuscular administration for the treatment of muscle injury following arthroplasty for HF.
- Trial name
- NCT03451916
- Testing
- PLX-PAD
- Where
- 17 sites in United States, Bulgaria and 3 more
- Volunteers
- 240 people
- Sponsor
- Pluristem Ltd.
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
Hip Fractures
Trigen InterTAN vs Sliding Hip Screw RCT
The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.
- Trial name
- NCT03065101
- Testing
- Trigen Intertan, Post-Surgery Follow Up, Sliding Hip Screw
- Where
- 5 sites in United Kingdom
- Volunteers
- 34 people
- Sponsor
- Smith & Nephew Orthopaedics AG
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
Distal Femur Fracture, Periprosthetic Fractures
Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.
- Conditions
- Distal Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures, Supracondylar Fracture
- Trial name
- NCT06028971
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 60 people
- Sponsor
- 41medical AG
Femoral Fracture (Proximal)
DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.
- Trial name
- ATN (NCT00546429)
- Testing
- Intramedullary nailing
- Where
- 4 sites in United States
- Volunteers
- 62 people
- Sponsor
- DePuy Orthopaedics
Tibial Fractures
ACTiF- Assessment of Closed Tibial Fractures
The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing…
- Trial name
- NCT00533377
- Testing
- CP-533, 536, Standard of Care, CP-533,536
- Where
- 56 sites in United States, Australia and 9 more
- Volunteers
- 276 people
- Sponsor
- Pfizer