Clinical trials: Implant Fracture
Kyphoplasty, Vertebroplasty
A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
The primary objective of this observational study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft in men and women aged ≥50…
- Conditions
- Kyphoplasty, Vertebroplasty, Vertebral Compression Fracture, Allograft
- Trial name
- PEARL ONE (NCT07561489)
- Testing
- Allograft
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Lenoss Medical
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Femur Fracture, Osteotomy
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical…
- Trial name
- NCT05339360
- Testing
- Femoral fixation with intramedullary nails
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Femoral Fractures
Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before…
- Trial name
- NCT01599221
- Testing
- EBA2
- Where
- 3 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Citieffe S.r.l
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Osteotomy, Trochanteric Fractures
ZNN Bactiguard Cephalomedullary Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit…
- Conditions
- Osteotomy, Trochanteric Fractures, Sub-trochanteric Fractures, Femoral Shaft Fracture
- Trial name
- NCT05362864
- Testing
- Fracture fixation via Intramedullary Nailing
- Where
- 3 sites in France, Spain
- Volunteers
- 149 people
- Sponsor
- Zimmer Biomet
Distal Radius Fractures, Degenerative Lumbar Spondylolisthesis
Long-term Safety Trial with NVDX3
An study evaluating the long-term safety of all patients previously treated with NVDX3.
- Trial name
- X3LTFU (NCT06532253)
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 15 people
- Sponsor
- Novadip Biosciences
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
Tibial Fracture
Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the…
- Trial name
- ALLOB-TF2 (NCT04432389)
- Testing
- ALLOB
- Where
- 39 sites in Belgium, Czechia and 5 more
- Volunteers
- 178 people
- Sponsor
- Bone Therapeutics S.A
Fracture Fixation, Internal, Distal Radius Fracture
RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
This is a pre-market, single-arm, open-label, monocenter clinical investigation evaluating the safety and performance of the magnesium (Mg)-based bioresorbable RemeOs™ DrillPin for surgical fixation of distal radius fractures in…
- Trial name
- NCT07028541
- Testing
- Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
- Volunteers
- 20 people
- Sponsor
- Bioretec Ltd.
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
Osteoarthritis, Rheumatoid Arthritis
Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement
Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis
- Trial name
- SPD (NCT00306917)
- Testing
- non-coated femoral hip stem, coated femoral hip stem
- Where
- United States
- Volunteers
- 245 people
- Sponsor
- DePuy Orthopaedics
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
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Hip Arthritis, Hip Disease
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II…
- Conditions
- Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT05199870
- Testing
- RingLoc Bipolar Acetabular Cup, Endo II Femoral Head
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Zimmer Biomet
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.
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
Fracture of Distal End of Radius
Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.
- Trial name
- VIPS (NCT01670344)
- Testing
- Treatment with investigational method (virtual implant positioning system), Treatment with surgical standard of care
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Siemens Healthcare QT
Zygomaticomaxillary Complex Fracture, Zygomatic Fractures
BoneTape Feasibility Trial
This study aims to evaluate the safety, effectiveness, and usability of BoneTape, an innovative medical device designed to fix facial bone fractures, specifically in the zygomaticomaxillary (midface) region.
- Conditions
- Zygomaticomaxillary Complex Fracture, Zygomatic Fractures, Zygoma Fracture
- Trial name
- NCT06600854
- Testing
- BoneTape
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Cohesys Inc.
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG