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

NCT02672696 | Unknown

• 1 other identifier: Fluoromap Gamma 3 nail
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fractures; Fracture Fixation, Internal; Trochanteric Fractures

Keywords

Navigation; Gamma Nail

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cut-out of the cephalic screw

  6 months

Study Arms (2)

FluoroMap group

EXPERIMENTAL

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

Test group

NO INTERVENTION

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.

Interventions

FluoroMap 3D DEVICE

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

Also known as: ADAPT System

FluoroMap group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hôpital du Valais: lead

Study Sites (1)

Hopital du Valais

Sion, Valais, 1951, Switzerland

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 3, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)