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Tibial Fractures clinical trials

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NCT ID: NCT05402995 Terminated - Clinical trials for Gustilo-Anderson Type III Open Tibia Fracture

Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

Start date: June 21, 2022
Phase: Phase 4
Study type: Interventional

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. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.

NCT ID: NCT04906642 Terminated - Clinical trials for Surgical Wound Infection

Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures

Start date: May 4, 2021
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03881241 Terminated - Tibial Fractures Clinical Trials

Safety Study of Treatment of Leg Fractures

EVOS SMALL
Start date: September 20, 2019
Phase:
Study type: Observational

This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.

NCT ID: NCT03042546 Terminated - Clinical trials for Open tíbia Fracture With Sub-segmental Bone Loss

Calcium Sulfate Spacer in Open Tibia Fractures

Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.

NCT ID: NCT03042533 Terminated - Clinical trials for Closed Transverse Fracture of Shaft of Tibia

Union Rate of Transverse Tibia Fracture

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.

NCT ID: NCT02951884 Terminated - Tibial Fractures Clinical Trials

Intra-articular Local Anesthetic Injection and Hematoma Aspiration

Start date: June 15, 2016
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.

NCT ID: NCT02845245 Terminated - Tibial Fractures Clinical Trials

Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques

CIDUCT
Start date: September 2016
Phase: N/A
Study type: Interventional

Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of high-energy trauma such as motor vehicle collisions or fall from a height. They are complex injuries often associated with significant fragment displacement and severe soft tissue injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and displacement. Yet, in some cases, it is still difficult to identify the relationship among bone fragments, which often makes articular restoration challenging. As a result, patients with non-anatomic joint reconstructions have a higher rate of poor outcomes. The primary objective of this study will be to compare patient outcomes in two groups, one group who will receive enhanced pre-operative planning (3D printed plastic prototype + standard of care [SOC] imaging with 3D CT scan + plain film radiographs) and a second group who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film radiographs only). Patient outcomes collected throughout the 12 month post-operative period will include an assessment of radiographic fracture healing (union, non-union, malunion), pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's self-report, and development of complications (infection, wound healing, re-operation, and re-hospitalizations). The secondary objective of this study will be to evaluate whether utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs only).

NCT ID: NCT02826538 Terminated - Fracture of Femur Clinical Trials

3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Start date: July 30, 2017
Phase: N/A
Study type: Interventional

Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.

NCT ID: NCT01927575 Terminated - Tibial Fracture Clinical Trials

Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury

TOMO
Start date: September 2013
Phase: N/A
Study type: Interventional

To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

NCT ID: NCT01553630 Terminated - Tibial Fractures Clinical Trials

Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia

Start date: May 2010
Phase: N/A
Study type: Interventional

Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved. Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures