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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672696
Recruitment Status : Unknown
Verified February 2016 by Hôpital du Valais.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Hôpital du Valais

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.

Condition or disease Intervention/treatment Phase
Femoral Fractures Fracture Fixation, Internal Trochanteric Fractures Device: FluoroMap 3D Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: 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.

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
Other Name: ADAPT System

No Intervention: 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.




Primary Outcome Measures :
  1. Tip-Apex distance [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Cut-out of the cephalic screw [ Time Frame: 6 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672696


Locations
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Switzerland
Hopital du Valais Recruiting
Sion, Valais, Switzerland, 1951
Contact: Jules Chauveau, Resident    +41788961069    jules.chauveau@me.com   
Contact: Sylvain Steinmetz, Senior resident    +41 78 836 96 93    steinmetzsylvain@gmail.com   
Sponsors and Collaborators
Hôpital du Valais
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Responsible Party: Hôpital du Valais
ClinicalTrials.gov Identifier: NCT02672696    
Other Study ID Numbers: Fluoromap Gamma 3 nail
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hôpital du Valais:
Navigation
Gamma Nail
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Hip Fractures
Wounds and Injuries
Leg Injuries
Hip Injuries