Clinical trials: Open Tibia Fracture
Tibial Fractures, Open Fracture of Tibia
Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania
The investigators propose to undertake a randomized, controlled trial which will generate Level 1 evidence concerning optimal fixation methods for the treatment of severe open tibia fractures in Dar es Salaam, Tanzania.
- Conditions
- Tibial Fractures, Open Fracture of Tibia, Trauma
- Trial name
- NCT03861624
- Testing
- Intramedullary nailing with standard SIGN nail, External Fixation with uniplanar Dispofix external fixator
- Volunteers
- 240 people
- Sponsor
- University of California, San Francisco
Open tíbia Fracture With Sub-segmental Bone Loss
Calcium Sulfate Spacer in Open Tibia Fractures
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
- Trial name
- NCT03042546
- Testing
- Calcium Sulfate, PMMA, No treatment
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Washington
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
Tibial Fractures
Bone Healing Accelerant Versus Standard of Care for 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
- NCT03826784
- Testing
- BHA
- Where
- United States
- Sponsor
- Carmell Therapeutics Corporation
Closed Fracture, Open Fracture
Efficacy of DBM on Fractures of the Shinbone (Tibia)
The Tibia bone (shinbone) is located in the leg, itis the most frequently fractured bone in the body and has very poor blood supply because it is surrounded by skin and fat instead of muscle like the thighbone causing healing…
- Trial name
- NCT00299052
- Testing
- Grafton DBM, Reamings
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Emory University
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
Fracture Open Tibia
Gentamicin Open Tibia Study
Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in…
- Trial name
- GO-Tibia (NCT05157126)
- Testing
- Gentamicin, normal Saline
- Where
- Tanzania
- Volunteers
- 890 people
- Sponsor
- University of California, San Francisco
Surgical Wound Infection
Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures
This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures
- Trial name
- NCT04906642
- Testing
- Next Science, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Next Science TM
Tibial Plateau Fractures
Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau
The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the…
- Trial name
- NCT06639503
- Testing
- Bupivacain
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Chicago
Tibial Plateau Fracture, Pain, Postoperative
Duloxetine Tibial Plateau
The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery.
- Trial name
- NCT04639011
- Testing
- Duloxetine, Standard of care (SOC) for tibial plateau surgery
- Where
- 2 sites in United States
- Sponsor
- Boston Medical Center
Tibia Fracture
OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting
A prospective, randomized, evaluator-blinded, controlled study for subjects with open tibial fractures classified as Gustilo type II, IIIA or IIIB (see Appendix 1) who will receive bone graft implantation for the potential of…
- Trial name
- NCT04960722
- Testing
- OIF/β-TCP
- Where
- Taiwan
- Volunteers
- 35 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Open Tibia Fracture, Open Dislocation of Ankle
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or…
- Conditions
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
- Trial name
- FLAP ATTACK (NCT07828613)
- Testing
- Accelerated Flap Coverage Surgery, Standard of Care Flap Timing
- Where
- 31 sites in United States
- Volunteers
- 356 people
- Sponsor
- Johns Hopkins University
Open Tibia Fracture
Low-cost Negative Pressure Wound Therapy vs Standard Dressings for Gustilo IIIb Tibial Fractures (Bukavu Pilot RCT)
Negative-pressure wound therapy (NPWT) is widely used in the management of acute and chronic wounds, but commercial systems are costly and may be inaccessible in low-resource settings.
- Trial name
- BukavuNPWTRC (NCT07790991)
- Testing
- intervention2: standard wound dressing, Intervention1: Low-cost NPWT
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 66 people
- Sponsor
- Université Catholique de Bukavu
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
Tibial Fracture
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures…
- Trial name
- NCT02820363
- Testing
- CERAMENT|G, SOC treatment
- Where
- 31 sites in United States, Germany and 2 more
- Volunteers
- 201 people
- Sponsor
- BONESUPPORT AB
Tibial Fractures, Fractures, Open
Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial…
- Trial name
- IMOCA (NCT00512434)
- Testing
- Osteosynthesis
- Where
- 11 sites in France
- Volunteers
- 85 people
- Sponsor
- University Hospital, Tours
Trauma
Adjunctive Therapy to Treat Tibial Shaft Fractures
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups…
- Trial name
- TSF (NCT00533793)
- Testing
- open fracture reduction
- Where
- 49 sites in Bulgaria, Czechia and 10 more
- Volunteers
- 201 people
- Sponsor
- Kuros Biosurgery AG
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
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
Gustilo-Anderson Type III Open Tibia Fracture
Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention
Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al.
- Trial name
- NCT05402995
- Testing
- Irrisept (Irrigation Solution), Saline
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Brett D. Crist