Efficacy and Safety Study of Non-percutaneous Vertebroplasty With Macroporous Calcium Phosphate Cement (MCPC) (VERTEBRO-MCPC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00931333
First received: June 30, 2009
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Vertebra Trauma
Procedure: non percutaneous vertebroplasty
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non Comparative, Monocentric, Prospective, Phase II, Study of Calcium Phosphate Cement MCPC Efficacy and Safety for Bone Filling in Vertebral Site

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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. [ Time Frame: At the 4th month after the surgical procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of Severe Adverse Events frequency (cement leak, new fractures, late huge loss of vertebra height) and inflammatory response [ Time Frame: before inclusion and at 3 months, 4 months, 5 months, 12 months ] [ Designated as safety issue: Yes ]
  • Pain intensity: difference between before inclusion and during follow up. Evaluation with Visual Analogic Scale. [ Time Frame: before inclusion and at 2 days, and 3, 4, 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life: difference between before inclusion and during follow up. Evaluation with OSWESTRY and SF 36 scales. [ Time Frame: before inclusion and at 2 days, and 3, 4, 6 and 12 months. ] [ Designated as safety issue: No ]
  • The evolution of bone formation and MCPC resorption: quantification of bone reconstruction. [ Time Frame: CT scan at 6 and 12 months after surgery, and with osteodensitometry at 3 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: non percutaneous vertebroplasty
The patient will undergo general anaesthetic. With a low invasive approach, 4 screws will be placed in pedicles of vertebra under and above the fractured vertebra. The reduction of the fracture will be realised by a smooth movement, and screws positions will be verified by a radio control, with a guided navigation system. The stems will be placed and locked. After the screw positioning, the fractured vertebra pedicles will be reached by a low invasive approach, using a 6 mm trocar, to raise, if necessary, the vertebral plate. Then the cement will be injected in the vertebral body, under radio control. When the maximal volume (6 to 8 ml) is reached, or if an extra vertebral leak is detected, the cement injection is stopped. Then the incision is closed. The next day, the patient will be placed in a corset for a 2 months period.

Detailed Description:

The macroporous calcium phosphate cement, MCPC, which composition is closer to bone than acrylic cement, is malleable and biocompatible, and has intrinsic radio opacity and good biomechanical properties (12 +/- 3 Mpa in 24 hours). After the filling of the bone cavity, the cement hardens in situ thanks to hydrolysis and apatite precipitation. Interestingly, this calcium phosphate cement has no exothermic hardening (on the contrary, the PMMA causes necrotic lesions in tissues around during this phase). During the dissolution, a macroporosity takes form between biphasic calcium phosphate granules. That permits vascularisation, cellular colonisation and bone healing. Thanks to its resorbability, the MCPC cement is replaced by a physiologic tissue. This last property is very important for young people needing a vertebroplasty after a traumatism.

The issue is to validate this biomaterial with appropriate mechanical, biocompatibility properties and intrinsic radio opacity, and that can favour bone regeneration, with a lower frequency of leak and risk enhancement of other vertebra fracture. The MCPC will thus be tested on few patients to assess its efficacy and security for bone filling in vertebra site.

Thus, it will be used 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 21 patients 1 to 3 weeks after the trauma having caused the fracture. The follow up will last 12 months with 5 visits.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931333

Locations
France
Service d'orthopédie-traumatolologie (C), Hôpital Pellegrin
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Jean-Charles LE HUEC, Professor University Hospital Bordeaux, France
Study Chair: Antoine BENARD, MD University Hospital Bordeaux, France
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00931333     History of Changes
Other Study ID Numbers: CHUBX 2009/03
Study First Received: June 30, 2009
Last Updated: November 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Vertebroplasty
spine
vertebra height
adverse events
calcium phosphate bone cement

ClinicalTrials.gov processed this record on July 29, 2014