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

Primary Purpose

Femoral Fractures, Fracture Fixation, Internal, Trochanteric Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FluoroMap 3D
Sponsored by
Hôpital du Valais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fractures focused on measuring Navigation, Gamma Nail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Hopital du ValaisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FluoroMap group

Test group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2016
Last Updated
February 6, 2016
Sponsor
Hôpital du Valais
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1. Study Identification

Unique Protocol Identification Number
NCT02672696
Brief Title
Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail
Acronym
INOPEG
Official Title
Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital du Valais

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures, Fracture Fixation, Internal, Trochanteric Fractures
Keywords
Navigation, Gamma Nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FluoroMap group
Arm Type
Experimental
Arm Description
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.
Arm Title
Test group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FluoroMap 3D
Other Intervention Name(s)
ADAPT System
Intervention Description
Use of the 3D reconstruction software developed by the manufacturer of the Gamma Nail (e.g. Stryker Inc.) along with the standard fluoroscopy
Primary Outcome Measure Information:
Title
Tip-Apex distance
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cut-out of the cephalic screw
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 Nail Exclusion Criteria: None
Facility Information:
Facility Name
Hopital du Valais
City
Sion
State/Province
Valais
ZIP/Postal Code
1951
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jules Chauveau, Resident
Phone
+41788961069
Email
jules.chauveau@me.com
First Name & Middle Initial & Last Name & Degree
Sylvain Steinmetz, Senior resident
Phone
+41 78 836 96 93
Email
steinmetzsylvain@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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