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

Femoral Fractures Clinical Trial

— INOPEG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672696
• Other study ID #: Fluoromap Gamma 3 nail
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: February 6, 2016
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2016
• Source: Hôpital du Valais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Fracture Fixation, Internal
• Fractures, Bone
• Hip Fractures
• Trochanteric Fractures

Intervention

Device:
• 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

Locations

Country	Name	City	State
Switzerland	Hopital du Valais	Sion	Valais

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tip-Apex distance	Change of the value of the tip-apex distance at each follow-up control (6 weeks, 3 and 6 months) compared to the post-op value	6 months	No
Secondary	Cut-out of the cephalic screw	Visualization of a migration of the tip of the cervical screw outside the femoral head on one radiological incidence will be considered as a "cut-out" and reported in the final results	6 months	No