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Tibial Fractures clinical trials

View clinical trials related to Tibial Fractures.

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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.

NCT ID: NCT01282294 Completed - Tibia Fractures Clinical Trials

Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures

Start date: February 2011
Phase: N/A
Study type: Observational

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, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.

NCT ID: NCT01183078 Completed - Tibial Fractures Clinical Trials

Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients

Sure Shot
Start date: August 2010
Phase: N/A
Study type: Interventional

Hypothesis: Utilization of the "wand" method will enhance improvements in drill placement, locking nail placement during tibia and femur fracture repairs, and offer less radiation exposure and less operative time. The purpose of this research study is to compare the efficacy of distal locking of intramedullary nails using a standard free-hand technique with the guided wand technique. Distal locking is the placement of screws through the intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays in order to find the holes in the intramedullary rod to place the screws. The wand technique uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of the wand technique could result in improvements in drill placement and locking nail placement as well as decrease operative time and radiation exposure.

NCT ID: NCT01134354 Completed - Clinical trials for Tibia Fracture (Isolated)

The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA

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

Design: Prediction trial, up to 10 sites in Asia and Europe Goal: To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM). Primary aim: To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population. Secondary aim: To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population. Key questions related to patient and surgeon expectations: - How different, or similar, are patient and surgeon expectations? - Do expectations change over time? - Do patient expectations predict outcomes in validated measures use today?

NCT ID: NCT01132508 Completed - Tibial Fractures Clinical Trials

Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

Start date: September 2008
Phase: N/A
Study type: Observational

Case series of tibial plateau fractures using Norian Drillable.

NCT ID: NCT01017094 Completed - Tibial Fracture Clinical Trials

Pin Site Infection Prevention for Open Tibial Fracture

Start date: September 2007
Phase: Phase 3
Study type: Interventional

This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing. Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.

NCT ID: NCT00888550 Completed - Tibia Fracture Clinical Trials

Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Start date: August 2007
Phase: N/A
Study type: Interventional

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience. The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.