NCT00521716

Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation

A Single Arm, Uni-Center, Prospective Clinical Investigation to Evaluate Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: OrthoMediTec · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Hip Fracture

Interventions

Type	Name	Description
DEVICE	Intracapsular Femoral Fracture Fixation	The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.
DEVICE	WaisFix100i for Intracapsular Femoral Fracture Fixation	The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-03-01
• Completion: 2009-12-01
• First posted: 2007-08-28
• Last updated: 2009-01-12

Locations

1 site across 1 country: Israel