Surgical Procedure, Unspecified
Conditions
Brief summary
The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.
Interventions
DEVICENavigation station coupled with a 3D fluoroscopy
After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.
Sponsors
PRAXIM company
AdministrateurCIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient aged over 18 years old * Patient affiliated to social security or similarly regime * Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac * Patient with a disease of the spine, with an indication of establishment of pedicle implant
Exclusion criteria
* Intubated patient resuscitation * Pregnant women and lactating mothers * Adult unable to express their consent * Ward of court or under guardianship * Person under legal protection * Person deprived of freedom by judicial or administrative decision * Person hospitalized without their consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM | two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measure radiation of the surgeon and the patient in the two groups | two years | delivered dose and irradiation time during the duration of the intervention for the sacro-iliac screw connections, or for the establishment of two pedicle screws in spinal surgery over a 2-D amplifier |
| Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier | two years | comparison of operating times of interventions between 3D-navigation and conventional methods |
Countries
France
Outcome results
None listed