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Femoral Fractures clinical trials

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NCT ID: NCT01673048 Completed - Children Clinical Trials

Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice

ESIN
Start date: January 2009
Phase: N/A
Study type: Interventional

Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Thus, a biomechanical study was conducted to search for modifications. In this study the stiffness with a 3rd nail implanted was compared to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm). Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department. All patients were followed prospectively. The following data was collected: Type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. At follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. Patients` satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age). Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.

NCT ID: NCT01667887 Completed - Clinical trials for Fracture of Distal Femur

Plating of Distal Femur Fractures by Far Cortical Locking Using MotionLoc Screws

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

The objective of this study is to document callus formation and healing of fractures stabilized with locking plates utilizing modern MotionLoc screws that provide controlled axial micro-motion to actively promote fracture healing.

NCT ID: NCT01660490 Completed - Clinical trials for Proximal Femur Fractures

Development and Validation of Intraoperative Image-quality Criteria

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

An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons. The panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.

NCT ID: NCT01647230 Recruiting - Clinical trials for Cognitive Impairment

Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

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

The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.

NCT ID: NCT01635166 Terminated - Clinical trials for Rheumatoid Arthritis

Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery

Start date: July 1, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

NCT ID: NCT01612208 Completed - Clinical trials for Fracture of the Distal Femur

MotionLoc Study, Femur Fractures

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

The objective of this study is to document callus formation and healing of fractures stabilized with locking plates utilizing modern MotionLoc screws that provide controlled axial micro-motion to actively promote fracture healing.

NCT ID: NCT01600027 Completed - Clinical trials for Children With Fracture Femur

Dexmedetomidine Addition to Fascia Iliaca Compartment Block

Start date: January 2012
Phase: Phase 1
Study type: Interventional

Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures of the mid-third of the femur which are intensely painful. The pain of the fracture is thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no need for high-skill or expensive equipments. It has higher success rate in more than 90%of the children thigh procedures. Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine and much less α1 effects, which is responsible for the hypnotic and analgesic effects. Perinural dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and motor block without neurotoxicity in experimental studies.It has been reported to improve the quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe and effective in IV regional anesthetic and axillary block in adult. No study-up to the date -has been carried to evaluate its effect on the character of fascia iliaca compartment blocks as adjuvant to bupivacaine. The objectives of this study were designed to detect the effects of addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia iliaca block on the quality of postoperative analgesia and also to determine its effects on the hemodynamics, recovery behaviors, sedation and possible side effects in children undergoing thigh surgeries (fracture femur).

NCT ID: NCT01599221 Active, not recruiting - Femoral Fractures Clinical Trials

Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2

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

This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before their surgery (retrospectively) until day 180 after surgery (retrospectively and prospectively). This study is aimed at collecting data from patients who have already been treated with EBA2 nail. Data collection will cover the details of the fracture and surgery (from which the retrospective nature of the study), as well as details of follow up visits after surgery that patients routinely carry out up to 6 months (from which the prospective nature of the study). The study will be conducted in three clinical sites in Italy.

NCT ID: NCT01593176 Recruiting - Clinical trials for Distal Femur Fractures

Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures

RSA
Start date: May 2012
Phase: N/A
Study type: Observational

The investigators are doing this research study to look at how distal femoral fractures (knee bone break) heal. In this study, the investigators will use Radiostereometric Analysis (RSA) to look at how the pieces of femur bone move as the bone heals. RSA is a special x-ray that uses radiographs to measure very small movements in the bone over time. The question that will be answered by this study is whether RSA can be used as a tool to monitor fracture healing.

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