Efficacy and Safety Study of Non-percutaneous Vertebroplasty With Macroporous Calcium Phosphate C… (NCT00931333) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety Study of Non-percutaneous Vertebroplasty With Macroporous Calcium Phosphate Cement (MCPC)
Stopped: target number of inclusion not reached
France4 participantsStarted 2009-07
Plain-language summary
The macroporous calcium phosphate cement, MCPC, which composition is close to bone, is malleable and biocompatible, and has intrinsic radio opacity and good ability to undergo mechanical constraints. After the filling of the bone cavity, the cement hardens. Interestingly, this calcium phosphate cement has no exothermic hardening (on the contrary, the ordinary cements used nowadays cause necrotic lesions in tissues around during this phase) and favours vascularisation, cellular colonisation and bone healing. Thanks to its resorbability, the MCPC cement is replaced little by little by a physiologic bone. This last property is very important for young people needing a vertebroplasty after a traumatism.
Thus, it will be tested in a low-invasive surgery, a non-percutaneous vertebroplasty, consisting in filling with the MCPC the body of the broken vertebra, after its stabilization thanks to 4 interpedicular screws. This protocol will be proposed to patients 1 to 3 weeks after the trauma having caused the fracture.
The follow up will last 12 months with 5 visits (2 days, and 3, 4, 6 and 12 months after vertebroplasty), 2 CT scanners before inclusion and at 12 months, 2 EOS (ultra low dose imager replacing classical radiography) at 5 and 12 months, questionnaires (visual analogic scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 2 days, and 3, 4, 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each visit except 2 days after surgery. An osteodensitometry will be performed at 3 months.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged between 18 and 65 years old, BMI \< 30
* Stable and important fracture of the vertebral body between T9 and L5
* Diagnostic maximum 3 weeks after the trauma causing the fracture
* Type A1 to A3 (MAGERL scale) assessed by CT scan
* Lumbar local traumatic angle \> 10°, and thoracic \> 15°
* Given informed consent
* Patient with French health system
Exclusion Criteria:
* For women: no efficient contraception (intra uterine device, or contraceptive pill)
* Pregnant or feeding women
* Fractures due to metastasis or multiple myeloma
* Symptomatic compression of the spinal cord
* Multi site vertebroplasty
* Scoliosis with a Cobb angle \> 20°
* Surgery zone local infection
* All surgical contraindications
* Immune system abnormalities, immune deficiency or suppression, HIV or BHV or CHV (positive serology)
* Severe hyperparathyroidism: calcium \> 2,45 mmol/l and \[PTH\] ≥ 50pg / ml
* Uncontrolled diabetes (untreated or non stabilized by treatment)
* Long corticoid treatment (more than 6 months and stopped since less than 3 months)
* Chemotherapy
* All contra indication to MCPC: osteomyelitis, bone degenerative disease or necrosis of surgery site.
* Known allergy to indigotine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completion — can you tell me why it was stopped early, and what that means for the reliability of any safety or effectiveness data that was collected?
2This study was testing a specific material called Macroporous Calcium Phosphate Cement injected through open surgery rather than through the skin — how does that surgical approach compare to what you would recommend for my type of vertebra injury, and what are the added risks?
3Since this was only a Phase 2 trial, meaning it was still in relatively early testing stages, what do we actually know so far about whether this cement material is safe and effective compared to more established vertebra repair options?
4The trial focused on patients aged 18 to 65 who had major trauma — given my specific injury and health situation, would a more standard or proven vertebroplasty approach be a better first option to consider?
5The study measured recovery by tracking vertebra height and the angle of the injured area over time — are those the right measures for my type of injury, and how would my progress be tracked if I pursued a similar treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The efficiency of non-percutaneous vertebroplasty using MCPC, in 18 to 65 years old patients, after a huge trauma, will be evaluated based on evaluation of the vertebra height by measuring local traumatic angle.
Timeframe: At the 4th month after the surgical procedure