Safety & Efficacy of the WaisFix100i for Intracapsular Femoral Fracture

Status Suspended

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.

Clinical Trial Description

Fractures of the neck of the femur represent an estimated cost to society that exceeds ten billion dollars annually in the USA only.

Fractures have been treated with immobilization, traction, amputation, and internal fixation throughout history. Immobilization by casting, bracing, or splinting a joint above and below the fracture was used for most long bone fractures.

Several studies have suggested that reduction and fixation of an Intracapsular fracture of the hip with multiple pins or screws is associated with a lower rate of morbidity and mortality than treatment with prosthetic replacement. With improved methods of fixation and a tendency toward earlier weight-bearing, internal fixation is believed to be a better mode of treatment for younger, more active patients.

On the other hand, the internal fixation procedure may result with number of possibilities for serious complications and biomechanical disadvantages, leading to the device failure. This led to a growing tendency to prefer total or partial hip replacement as the common treatment for intracapsular fracture, although the internal fixation is the favorable procedure in the professional literature.

OrthoMediTec has developed the WaisFix100i device, a new concept for Intracapsular Femoral Fracture Fixation and bone grafting using minimally invasive procedures. The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.

The Internal Triangular Cage is inserted into the femoral neck as a strong, solid beam structure to guide and hold the screws in place. The cage supplies the structure to hold the bone graft and screws at the fracture site.

The objectives of this single arm, multi-center, prospective study, are to evaluate the safety and efficacy of using the WaisFix100i device in intracapsular femoral fracture fixation surgery. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00521716
Study type	Interventional
Source	OrthoMediTec
Contact
Status	Suspended
Phase	N/A
Start date	September 2007
Completion date	December 2009

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms