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Tibial Fractures clinical trials

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NCT ID: NCT02301832 Completed - Tibial Fractures Clinical Trials

Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

Start date: December 2014
Phase: N/A
Study type: Observational

This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).

NCT ID: NCT02140528 Completed - Tibial Fracture Clinical Trials

Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Start date: August 2013
Phase: Phase 2
Study type: Interventional

This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

NCT ID: NCT02064595 Completed - Open tíbia Fracture Clinical Trials

Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail

Start date: January 2011
Phase: N/A
Study type: Interventional

The objective of this research is to prospectively evaluate a group of patients with shaft compound fracture of the tibia, treated with a biplanar external fixator or locked intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and postoperative complications.

NCT ID: NCT02056834 Completed - Clinical trials for Closed Proximal Tibial Fracture AO-OTA 42

chronOS Inject in Proximal Tibial Fractures

Start date: March 2010
Phase: N/A
Study type: Observational

The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.

NCT ID: NCT01926795 Completed - Tibial Fractures Clinical Trials

Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial

Start date: June 2013
Phase: N/A
Study type: Interventional

Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing & bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.

NCT ID: NCT01879215 Completed - Clinical trials for Acute Tibial Fracture Requiring Intramedullary Nailing

T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

Start date: June 2013
Phase: N/A
Study type: Interventional

This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs. the suprapatellar approach. Subjects will be randomized to one or the other standard care surgical approaches.

NCT ID: NCT01828905 Completed - Clinical trials for AO 41-B2 and AO 41-B3 Tibia Fractures

Cerament Treatment of Fracture Defects

CERTiFy
Start date: April 2013
Phase: N/A
Study type: Interventional

The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENTâ„¢|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.

NCT ID: NCT01797640 Completed - Tibial Fractures Clinical Trials

Intramedullary Nailing of Tibia Fractures

Start date: October 2012
Phase: N/A
Study type: Observational

Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.

NCT ID: NCT01691599 Completed - Tibia Fracture Clinical Trials

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India

Start date: August 2012
Phase:
Study type: Observational

The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions: 1. What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation? 2. What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation? Secondary objectives 1. How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation? 2. What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation? 3. What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation? 1. Hospital standard hygienic and antibiotic protocol for infection prevention 2. Subject demographics 3. Time between injury and surgery and between admission and surgery 4. Fracture type (AO Müller classification) 5. Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures) 6. Fracture management and implant type 7. Surgical details such as duration of surgery 4. Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections? 5. Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?

NCT ID: NCT01494519 Completed - Clinical trials for Severe Open Fractures of the Tibia (Shin) Bone

Assessment of Fixation Strategies for Severe Open Tibia Fractures

FIXIT
Start date: July 2011
Phase: Phase 3
Study type: Interventional

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.