Clinical trials: Intramedullary
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
Fracture
NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.
- Trial name
- NCT00969839
- Testing
- NovaLign Intramedullary Fixation System
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- NovaLign Orthopaedics, Inc
Thoracic Spinal Cord Injury, Spinal Cord Injury
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.
- Conditions
- Thoracic Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Trauma
- Trial name
- NCT01321333
- Testing
- HuCNS-SC cells
- Where
- 3 sites in Canada, Switzerland
- Volunteers
- 12 people
- Sponsor
- StemCells, Inc.
Tibial Fractures
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical…
- Trial name
- TrigenMETA (NCT01358292)
- Testing
- Semi-extended Surgical Technique, Standard Surgical Technique
- Where
- 5 sites in Germany, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Smith & Nephew Orthopaedics AG
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
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.
Osteoarthritis, Varus Malalignment
Ellipse Intramedullary High Tibial Osteotomy Nail Study
The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.
- Trial name
- NCT02519218
- Testing
- Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System
- Volunteers
- 6 people
- Sponsor
- Ellipse Technologies, Inc.
Arthrodesis, Bunion
Early Weight-Bearing After Lapidus Arthrodesis
The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Trial name
- NCT03257540
- Testing
- Small Bone Intramedullary Nail
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Paragon 28
Spinal Cord Injury
Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.
- Trial name
- NCT01725880
- Testing
- Observation
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- StemCells, Inc.
Leg Length Inequality
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more…
- Trial name
- FitForFrance (NCT06156384)
- Testing
- FITBONE® Lengthening Nail
- Where
- 6 sites in France, Reunion
- Volunteers
- 45 people
- Sponsor
- Orthofix s.r.l.
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.
Humeral Fractures, Pathological Fractures
Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
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
- NCT01087463
- Testing
- Quantum
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- N.M.B. Medical Applications 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
Fracture Healing
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).
- Trial name
- STARTT (NCT00907296)
- Testing
- Romosozumab
- Where
- 103 sites in United States, Australia and 21 more
- Volunteers
- 402 people
- Sponsor
- Amgen
Ankle Arthritis, Arthritis Foot
The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic…
- Trial name
- NCT04831645
- Testing
- DynaNail, Tibiotalocalcaneal Arthrodesis
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- MedShape, 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
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.
Osteoarthritis, Varus Malalignment
Ellipse Intramedullary Nail High Tibial Osteotomy Study
This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee.
- Trial name
- IM HTO (NCT02412163)
- Testing
- Ellipse IM HTO Nail
- Where
- 11 sites in Germany, Netherlands and 2 more
- Volunteers
- 41 people
- Sponsor
- Ellipse Technologies, Inc.
Femoral Neck Fractures, Intertrochanteric Fracture
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures.
- Trial name
- INSITE (NCT01380444)
- Testing
- Gamma3 Intramedullary Nails (Stryker), Sliding Hip Screws
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 880 people
- Sponsor
- Stryker Trauma and Extremities
Arthrodesis, Bunion
Multi-Plane Hallux Valgus Correction With the Phantom® Nail
The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combined with a supinating…
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Trial name
- NCT04084262
- Testing
- Intramedullary Nail
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Paragon 28