Clinical trials: Fracture Fixation
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.
Ankle Fracture Requiring Internal Fixation
Midds Ankle Fracture
The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle…
- Trial name
- NCT02841007
- Testing
- geko neuromuscular electrostimulation device
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Firstkind Ltd
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
Spinal Fractures, Vertebral Compression Fractures
Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus…
- Conditions
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Osteoporosis
- Trial name
- SAKOS (NCT02461810)
- Testing
- Vertebral fracture surgery SpineJack®, Balloon Kyphoplasty
- Where
- 13 sites in France, Germany and 3 more
- Volunteers
- 152 people
- Sponsor
- Vexim SA
Surgery
Inion OTPS Biodegradable Fixation System for the Ankle
The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.
- Trial name
- NCT00300989
- Testing
- Inion OTPS Biodegradable Fixation System
- Where
- Finland
- Volunteers
- 43 people
- Sponsor
- Inion Oy
Traumatic Amputation of Lower Extremity
Intraosseous Transcutaneous Amputation Prosthesis
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
- Trial name
- (ITAP) (NCT02491424)
- Testing
- Direct skeletal fixation of ITAP to lower limb amputees.
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Stryker Orthopaedics
Tibial Plateau Fracture
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
This study will compare two approaches to rehabilitation after surgery for a fracture of the upper part of the shinbone that involves the knee joint (tibial plateau fracture).
- Trial name
- NCT07897149
- Testing
- Crutch Tip Biofeedback System, Individualized FEA-Guided Postoperative Weight-Bearing, Usual-Care Postoperative Weight-Bearing
- Volunteers
- 86 people
- Sponsor
- Comeback Mobility Inc
Fibula Fracture
Effectiveness Of The Fibulock Intramedullary Nail
The objective of this post-market clinical study is to evaluate efficacy outcomes and complication rates in patients who have received the Fibulock™ Intramedullary Nail.
- Trial name
- Fibulock (NCT02688296)
- Testing
- Fibulock
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Arthrex, Inc.
Femoral Neck Fracture
Dynamic Internal Fixation of Femoral Neck Fractures
Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.
- Trial name
- DIFINE (NCT00779948)
- Where
- 9 sites in Germany
- Volunteers
- 171 people
- Sponsor
- Aesculap AG
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.
Humeral Fractures, Pathological Fractures
Intramedullary Fixation of Humerus Fractures
The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.
- Trial name
- NCT01017289
- Testing
- Quantum
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- N.M.B. Medical Applications Ltd
SPINAL Fracture, Vertebral Fractures
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients…
- Conditions
- SPINAL Fracture, Vertebral Fractures, Spinal Stenosis, Kyphosis
- Trial name
- NCT06153511
- Testing
- Robot assisted spinal transpedicular fixation
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Cyber Surgery S.L.
Fracture Healing
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
- Trial name
- STARTT-Hip (NCT01081678)
- Testing
- Romosozumab
- Where
- 99 sites in United States, Argentina and 22 more
- Volunteers
- 332 people
- Sponsor
- Amgen
Vertebral Compression Fractures
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA)…
- Trial name
- OsseoFix (NCT00961714)
- Testing
- OsseoFix Spinal Fracture Reduction System
- Where
- 11 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Alphatec Spine, 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
AO/OTA Type 2R3C Distal Radius Fracture
A Pilot Clinical Study to Evidence Safety and Efficacy of Fracture Fixation of the Distal Radius Using a Bioresorbable Bone Adhesive to Augment Metal Hardware
A prospective, multi-center (up to 4 sites), single-arm, study of 20 subjects. Patient enrollment will consist of subjects with an AO/OTA type 2R3C distal radius fracture.
- Trial name
- NCT07452536
- Testing
- Augmented with Tetranite Bone Adhesive
- Volunteers
- 20 people
- Sponsor
- RevBio
Intervertebral Disc Disease, Spondylolisthesis
PASS OCT® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
- Conditions
- Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms
- Trial name
- NCT02931279
- Testing
- PASS OCT® Spinal System
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Medicrea International
Pelvic Ring Fracture, Acetabular Fracture
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
- Conditions
- Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum
- Trial name
- NCT05606042
- Testing
- IM Implant
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- CurvaFix, Inc.
Clavicle Fracture, Clavicle Injury
A.L.P.S. Clavicle Plating System PMCF
A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used…
- Trial name
- NCT05327959
- Testing
- Clavicle open reduction and internal fixation
- Where
- 5 sites in United States, Spain
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Pathologic Fracture
Performance and Safety of the Innofix® Screw (IF25)
The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of…
- Trial name
- IF25 (NCT06800417)
- Testing
- Percutaneous fixation by internal cemented screw (InnoFix®)
- Volunteers
- 34 people
- Sponsor
- Innoprod Medical