Clinical trials: Open Fracture Tibia
Osteomyelitis Tibia, Tibial Fractures
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
- Conditions
- Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
- Trial name
- NCT05421741
- Testing
- Antibiotic coated intramedullary Nail, Standard Intramedullary Nail
- Where
- 15 sites in United States
- Volunteers
- 242 people
- Sponsor
- Wake Forest University Health Sciences
Tibia Fracture
Ilizarov Frame or Uni Planar External Fixator in the Cost-conscious Era
Tibial shaft fracture is a common injury worldwide. Their treatment, prognosis, and outcome are determined by the mechanism of injury, presence of communition, soft tissue injury and displacement.
- Trial name
- NCT03936972
- Testing
- ilizarov circular frame and uni-planarexternal fixator
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Severe Open Fractures of the Tibia (Shin) Bone
Assessment of Fixation Strategies for Severe Open Tibia Fractures
The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
- Trial name
- FIXIT (NCT01494519)
- Testing
- Surgery with an external ring fixator, Definitive fixation with a locked IM nail or plate
- Where
- 33 sites in United States
- Volunteers
- 442 people
- Sponsor
- Major Extremity Trauma Research Consortium
Pain, Acute
SOFT Block Versus Spinal Anesthesia in Patientsusing Ilizarov External Fixator
Peripheral nerve block is an ideal choice for lower limb surgery because of the peripheral site of the surgical procedure and the ability to block pain pathways at multiple levels.
- Trial name
- NCT03450798
- Testing
- SOFT block group, spinal anesthesia group
- Where
- Egypt
- Volunteers
- 107 people
- Sponsor
- Ain Shams University
Open Fracture
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.
- Trial name
- Bioburden (NCT01496014)
- Where
- 40 sites in United States
- Volunteers
- 646 people
- Sponsor
- Major Extremity Trauma Research Consortium
Reconstructive Surgical Procedure
Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique
This study assesses the long-term results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital.
- Trial name
- NCT02369991
- Testing
- Reconstructive surgery
- Where
- Finland
- Volunteers
- 9 people
- Sponsor
- Helsinki University Central Hospital
Fractures, Open
Ganga Hospital Scoring System In Type-IIIA/B Open Tibial Fractures
The aim of this study is to assess interobserver reliability, sensitivity for amputation, and specificity for salvage of GHS in type-III injuries with open tibial fractures and predict the potential number of inpatient days…
- Trial name
- NCT05435261
- Testing
- BKA, Debridement with Ex_Fix (salvage)
- Volunteers
- 87 people
- Sponsor
- Assiut University
Open Fracture of Tibia
Role of Vacuum in Open Fracture Tibia Grade III Type B
Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
- Trial name
- NCT04063111
- Testing
- vacuum assistant closure, CONVENTIONAL DRESSING
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assiut University
Fracture of Calcaneus, Pilon or Tibial Plateau
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating soft tissue injuries and the surgical incision following open reduction and internal…
- Trial name
- VAC-ST (NCT00582998)
- Testing
- Standard Wound Dressing, Vacuum Assisted Closure Device
- Where
- United States
- Volunteers
- 249 people
- Sponsor
- University of Alabama at Birmingham
Tibial Fractures
Multiregion BHA in Open Tibia Fractures
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open…
- Trial name
- NCT04056429
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Fractures, Bone, Nonunion of Fracture
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union…
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited
- Trial name
- NCT04299022
- Testing
- Vivigen Cellular Bone Matrix
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- LifeNet Health
Open Tibia Fracture
Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania
Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in…
- Trial name
- pGO-Tibia (NCT03559400)
- Testing
- local gentamicin injection
- Where
- Tanzania
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tibial Fractures
Safety Study of Treatment of Leg Fractures
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
- Trial name
- EVOS SMALL (NCT03881241)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Smith & Nephew, Inc.
Open tíbia Fracture
Management of Open Fracture Tibia in Teenagers
The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes
- Trial name
- NCT06288139
- Volunteers
- 100 people
- Sponsor
- Assiut University
Ankle Fractures
Open Reduction Syndesmosis Tightrope Versus Screw Fixation
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments.
- Trial name
- NCT02199249
- Testing
- Open reduction Tightrope fixation, open reduction screw fixation
- Where
- Canada
- Volunteers
- 103 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Open tíbia Fracture, Osteomyelitis Tibia
Intramedullary Calcium Sulfate Antibiotic Depot
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate…
- Conditions
- Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
- Trial name
- NCT05766670
- Testing
- Vancomycin Hydrochloride, Gentamicin, Standard Intramedullary Nail
- Where
- 12 sites in United States
- Volunteers
- 242 people
- Sponsor
- Wake Forest University Health Sciences
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
Tibia Fractures
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D…
- Trial name
- NCT01282294
- Testing
- ETN PROtect
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Synthes GmbH
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.
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