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Tibial Fractures clinical trials

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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: NCT01795287 Recruiting - Tibial Fracture Clinical Trials

Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture

Start date: March 2012
Phase: N/A
Study type: Interventional

There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.

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: 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

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.

NCT ID: NCT01358292 Completed - Tibial Fractures Clinical Trials

Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails

TrigenMETA
Start date: February 2011
Phase: Phase 4
Study type: Interventional

Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2*100 patients) Research Objectives: The primary research objectives are to evaluate: i) anterior knee pain and ii) the nail position and overall fracture alignment Outcome Measures: 1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays. 2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires 3. Knee-related adverse events 4. Overall fracture alignment

NCT ID: NCT01341418 Completed - Tibial Fractures Clinical Trials

Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

SP-Pilot
Start date: April 2011
Phase: N/A
Study type: Interventional

This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.

NCT ID: NCT01316289 Completed - Clinical trials for Pilon Fracture of Tibia

Pilon Fracture Reduction and Functional Outcome

Start date: November 2011
Phase:
Study type: Observational

This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. The plates used in this trial can be chosen according to the preferences of the surgeon.

NCT ID: NCT01315392 Completed - Clinical trials for Type II and IIa Open Tibia Fractures

A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures

Start date: July 2000
Phase: N/A
Study type: Interventional

Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.