Clinical trials: Intramedullary
Femur Fracture
Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals
This project is designed to determine whether or not the trochanteric insertion portal will show any difference when compared with the piriformis fossa portal in terms of pain and strength of the hip abductor muscles, while…
- Trial name
- TROCHNAIL (NCT00593333)
- Testing
- Antegrade Intramedullary Nail, Trigen Trochanteric Femoral Nail
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- University of Alabama at Birmingham
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
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.
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
Bone Metastases, Cancer Survivor
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
This randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone.
- Conditions
- Bone Metastases, Cancer Survivor, Metastatic Malignant Neoplasm in the Bone
- Trial name
- NCT02715856
- Testing
- Monitoring Device, Physical Activity Measurement, Quality-of-Life Assessment
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- M.D. Anderson Cancer Center
Pain, Postoperative
Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia
The purpose of this study is to determine whether, for surgery of the tibia, one dose of methadone provides better control of pain afterward as compared to morphine, which is the usual drug given to control pain after surgery.
- Trial name
- NCT01430182
- Testing
- Methadone, Morphine
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Baylor College of Medicine
Distal Radius Fractures
Fixation of Unstable Distal Radius Fractures
Wrist fractures are the most common type of fractures that occur in the shoulder, arm, and hand. Approximately 250,000 to 300,000 wrist fractures occur in the United States each year.
- Trial name
- NCT00654615
- Testing
- Intramedullary Radius Fixation (Micronail), Volar Plate Fixation
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Wake Forest University
Fracture Fixation, Intramedullary, Surgical Wound Infection
Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Diaphyseal femoral and tibial fractures are in the spotlight within the traumatology-orthopedics scenario. Intramedullary nailing (IMN) remains the method of choice for treating these fractures, both open and closed ones.
- Trial name
- NCT03148067
- Testing
- Intramedullary nailing for fracture fixation
- Volunteers
- 225 people
- Sponsor
- University of Sao Paulo
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
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
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
Hip Fractures
Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures
The purpose of this study is to look at the effect of locking or not locking a set screw when placing a rod and screws device in the thigh bone and hip to fix hip fractures.
- Trial name
- NCT02345369
- Testing
- Locked Set Screw, Unlocked Set Screw
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Bassett Healthcare
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.
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
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
Radiation Exposure
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
The purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail…
- Trial name
- NCT02856828
- Testing
- DIE
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Duke University
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
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
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.