NCT01335841CompletedPhase 3
Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis
AdministrateurCIC1 site in 1 country150 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
Time Frame: two years
Secondary Outcomes
- measure radiation of the surgeon and the patient in the two groups(two years)
- 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)
Investigators
AdministrateurCIC
principal investigator
University Hospital, Grenoble
Study Sites (1)
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