Clinical trial NCT01402167: Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures
Official title: Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vertebral Body Compression Fractures
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow-up
* Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
* Cyphose of \>10°
* Spinal pain
* Vertebral fracture \< 3 weeks old located between D5 and L5
* If fragments in the canal, they must protrude less than 40%
* Absence of other lesions, including cancer

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient cannot read French
* Patient is pregnant or breast feeding
* Patient has a fracture on an adjacent vertebra
* Patient has a contra-indication for a treatment used in this study
* ASA class IV or V
* Patient has a neurological deficit
* Previous spinal surgery

Primary outcomes:
measure: The volume (cm^3) of injected ciment
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Recovery of vertebral volume (%)
timeFrame: Day 1 to Day 7
measure: Change from baseline of the cyphotic angle (°)
timeFrame: Days 1 to 7
measure: Change from baseline of the cyphotic angle (°)
timeFrame: 1 month
measure: Change from baseline of the cyphotic angle (°)
timeFrame: 3 months
measure: Change from baseline in vertebral height (mm)
timeFrame: Days 1 to 7
measure: Change from baseline in vertebral height (mm)
timeFrame: 1 month
measure: Change from baseline in vertebral height (mm)
timeFrame: 3 months
measure: Volume of ciment leakage (cm^3)
timeFrame: Day 1
measure: Change in Visual Analog Scale (0 to 10) for pain before and after surgery
timeFrame: Day 0 (post-op)
measure: Change in Visual Analog Scale (0 to 10) for pain before and after surgery
timeFrame: 1 month
measure: Change in Visual Analog Scale (0 to 10) for pain before and after surgery
timeFrame: 3 months
measure: % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
timeFrame: Day 0 (post-op)
measure: % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
timeFrame: 1 month
measure: % Change in Visual Analog Scale (0 to 10) for pain before and after surgery
timeFrame: 3 months
measure: The change in the ODI score before and after surgery
timeFrame: 3 months
measure: The % change in the ODI score before and after surgery
timeFrame: 3 months
measure: Change in SF-36 quality of life score before and after surgery
timeFrame: 1 month
measure: Change in SF-36 quality of life score before and after surgery
timeFrame: 3 months
measure: The % change in SF-36 quality of life score before and after surgery
timeFrame: 1 month
measure: The % change in SF-36 quality of life score before and after surgery
timeFrame: 3 months
measure: Change in FABQ score before and after surgery
timeFrame: 1 month
measure: Change in FABQ score before and after surgery
timeFrame: 3 months
measure: % Change in FABQ score before and after surgery
timeFrame: 1 month
measure: % Change in FABQ score before and after surgery
timeFrame: 3 months
measure: Change in DPQ score before and after surgery
timeFrame: 1 month
measure: Change in DPQ score before and after surgery
timeFrame: 3 months
measure: % Change in DPQ score before and after surgery
timeFrame: 3 months
measure: % Change in DPQ score before and after surgery
timeFrame: 1 month
measure: Duration of surgery (minutes)
timeFrame: Day 0 (day of surgery)
measure: Presence / absence of per-operative complications
timeFrame: Day 0 (day of surgery)
measure: Presence / absence of post-operative complications
timeFrame: 1 month
measure: Presence / absence of post-operative complications
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pascal Kouyoumdjian, MD
role: PRINCIPAL_INVESTIGATOR
References: