Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail

NCT ID: NCT02672696

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-05-31

Brief Summary

The aim of the study is to compare Tip-Apex Distance values in two groups of patients after intramedullary nailing of proximal femur. The first group of patients is operated with the help of a 3D reconstruction device connected to the standard fluoroscopy allowing the surgeon to visualize directly the exact position of the tip of the trans-cervical screw while the second group (which is the reference-group) is operated with the help of fluoroscopy alone.

Detailed Description

The main orthopedic complication after fixation of a proximal femoral fracture with a cephalo-medullary nail is the cut-out of the cephalic screw from femoral head resulting in a protrusion of this screw in the coxo-femoral joint, mostly during the first 6 months after the operation. In most cases, the surgeon has to remove the primary implant and perform a total hip arthroplasty to his patient, therefore rising the morbidity and social costs linked to the treatment of the initial fracture.

Baumgartner showed the importance of the position of the cephalic screw for predicting failure of the implant and proposed a new measurement to evaluate this position, the tip-apex distance which is the sum of the distance from the tip of the cephalic screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. He showed a lower TAD was associated with a lower risk of cut-out.

The aim of this study is to evaluate the help of a 3D reconstruction software linked to the standard fluoroscopy in achieving the lowest TAD and therefore minimizing the cut-out rate.

Conditions

Femoral Fractures; Fracture Fixation, Internal; Trochanteric Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FluoroMap group

Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 nail (Stryker Inc).

In this group, the surgeon will use the FluoroMap 3D reconstruction system (Stryker Inc) with the standard fluoroscopy to help him place the cephalic screw in the femoral head.

Group Type: EXPERIMENTAL

FluoroMap 3D

Intervention Type: DEVICE

Use of the 3D reconstruction software developed by the manufacturer of the Gamma Nail (e.g. Stryker Inc.) along with the standard fluoroscopy

Test group

Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 nail (Stryker Inc).

In this group, the surgeon will use only the standard fluoroscopy to help him visualize the position of the cephalic screw in the femoral head.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FluoroMap 3D

Use of the 3D reconstruction software developed by the manufacturer of the Gamma Nail (e.g. Stryker Inc.) along with the standard fluoroscopy

Intervention Type: DEVICE

Other Intervention Names

ADAPT System

Eligibility Criteria

Inclusion Criteria

• Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 Nail

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital du Valais

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital du Valais

Sion, Valais, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Jules Chauveau, Resident

Role: primary

jules.chauveau@me.com

+41788961069

Sylvain Steinmetz, Senior resident

Role: backup

steinmetzsylvain@gmail.com

+41 78 836 96 93

Other Identifiers

Fluoromap Gamma 3 nail

Identifier Type: -

Identifier Source: org_study_id