Pedicular Screwing Clinical Trial
Official title:
Comparison of the Malposition Rates of the Vertebral Pedicle Screws Using the PediGuard Technique: PediGuard Technique Associated With Fluoroscopy and Fluoroscopy Alone
| Verified date | July 2017 |
| Source | Brugmann University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Pedicular screwing has become the gold standard for intervertebral fixation required in
degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing
methods exist.
The free hand pedicular screwing requires a high learning curve and has, as a consequence, a
high malposition rate.
The placing of pedicular screws under fluoroscopic control is the most common technique as it
is both reproducible and accessible. It is a two dimensional imaging technique. The profile
incidence at the level of the spine is mostly used to spot the vertebral pedicle and the
direction of the screw in the sagittal plane. However, there is no real control of the
direction of the pedicular screw in the horizontal or frontal plane. The screw malposition
rate is less important than with the 'free hand' technique but remains none of the less
significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the
patient and the staff.
New revolutionary techniques as the tridimensional navigation and the per-operatory
tomodensitometry appeared in the last few years. The techniques give the best results when
used concommitantly. The material has the advantage of being very precise. The pedicular
screw malposition rate is minimal after a three-dimensional localisation. However, those
systems require qualified staff and expose the patient and the nursing team to high radiation
levels. The costs are higher and the surgery duration is globally longer. It is thus
difficult to implement this technique in each belgian hospital.
Finally, the Pediguard technique appeared on the market. It is a guide for the perforation of
the pedicular channel, with a probe at its extremity. This probe allows a real time
measurement of the electric conductivity of the tissues that are being crossed. The
conductivity measure is translated in a sound signal. Because the cortical bone has a low
conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a
medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the
event of a breach in the pedicular cortical, as blood and periost have a high conductibility,
the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to
anticipate a cortical effraction, by detecting the proximity of the cortical wall. It is
efficient but remains relatively expensive.
The main objective of this study is to determine the precision of the placing of pedicular
screws, with and without Pediguard system, under fluoroscopy.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients needing vertebral instrumentation with pedicular screwing Exclusion Criteria: - Contra-indication to the placement of pedicular screws under fluoroscopy |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Brugmann University Hospital |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pedicular effraction grade | Evaluation of screw malposition, performed under CT-scan and graded according to the following: 0 (no effraction), grade 1 (effraction up to 2 mm), grade 2 (effraction between 2 and 4 mm), grade 3 (effraction of more than 4 mm). | Between 24 and 48h after surgery | |
| Primary | Pedicular effraction grade | Evaluation of screw malposition, performed under CT-scan and graded according to the following: 0 (no effraction), grade 1 (effraction up to 2 mm), grade 2 (effraction between 2 and 4 mm), grade 3 (effraction of more than 4 mm). | 1 year after surgery | |
| Secondary | Oswestry Disability Index (ODI) | Clinical functional scoring, assessed before the surgical intervention. | Baseline | |
| Secondary | Oswestry Disability Index (ODI) | Clinical functional scoring | 1 year after surgery | |
| Secondary | SF-36 questionnaire | Quality of life evaluation, assessed before the surgical intervention. | Baseline | |
| Secondary | SF-36 questionnaire | Quality of life evaluation | 1 year after surgery |