Clinical trials: Intramedullary Nail
Tibial Shaft Fractures
Carbon Fiber Implants
The investigators will compare intramedullary nailing of open and closed tibia shaft fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.
- Trial name
- NCT03382041
- Testing
- Carbon Fiber Implant, Titanium Implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Osteogenesis Imperfecta
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.
- Trial name
- JTIN (NCT05612139)
- Testing
- JTIN implantation surgery
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Orthofix s.r.l.
Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur
Retrospective Study Chimaera Long Nail in Adult Patient
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
- Conditions
- Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur, Subtrochanteric Fracture of Femur
- Trial name
- NCT06285981
- Testing
- Chimaera Long Nail
- Where
- 2 sites in Italy
- Volunteers
- 44 people
- Sponsor
- Orthofix s.r.l.
Tibial Fractures
Study Evaluating InductOs in Diaphyseal Tibia Fractures
Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.
- Trial name
- NCT00161616
- Testing
- InductOs
- Where
- 27 sites in Belgium, Finland and 10 more
- Volunteers
- 277 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Subtalar Arthritis, Ankle Arthritis
Compression Nail for Tibiocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis
- Trial name
- NCT03780452
- Testing
- novel dynamic compression intramedullary nail
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Alabama at Birmingham
Femoral Fractures
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely)…
- Trial name
- NCT00429663
- Testing
- reamed, interlocking intramedullary nail, locking periarticular plate
- Where
- 22 sites in United States
- Volunteers
- 160 people
- Sponsor
- Boston Medical Center
Embolism, Femoral Fractures
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
The purpose of this study is to determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures
- Trial name
- RIA (NCT00509171)
- Testing
- Reamer Irrigator Aspirator
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Tibial Fractures
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and…
- Trial name
- NCT00429585
- Testing
- reamed, interlocking intramedullary nail, locking periarticular plate
- Where
- 29 sites in United States, Canada
- Volunteers
- 108 people
- Sponsor
- Boston Medical Center
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
Intertrochanteric Femur Fractures
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures.
- Trial name
- NCT02190435
- Testing
- Stryker ADAPT computer-assisted navigation, Conventional technique
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Corewell Health East
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.
Fracture of Clavicle
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the…
- Trial name
- NCT01975467
- Testing
- CRx
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Sonoma Orthopedic Products, Inc.
Closed Transverse Fracture of Shaft of Tibia
Union Rate of Transverse Tibia Fracture
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.
- Trial name
- NCT03042533
- Testing
- Conventional Compression, Standard Backslapping, Dynamic Locking with Backslapping
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Washington
Femur Fracture, Tibial Fractures
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures…
- Trial name
- NCT04761302
- Testing
- Intravenous ketorolac and oral acetaminophen, Intravenous morphine and oral oxycodone
- Where
- Puerto Rico
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- University of Puerto Rico