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

May 20, 2026 updated by: University Hospital, Bordeaux

Non Comparative, Monocentric, Prospective, Phase II, Study of Calcium Phosphate Cement MCPC Efficacy and Safety for Bone Filling in Vertebral Site

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service d'orthopédie-traumatolologie (C), Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At the 4th month after the surgical procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
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
before inclusion and at 3 months, 4 months, 5 months, 12 months
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
before inclusion and at 2 days, and 3, 4, 6 and 12 months
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.
before inclusion and at 2 days, and 3, 4, 6 and 12 months.
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
CT scan at 6 and 12 months after surgery, and with osteodensitometry at 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-Charles LE HUEC, Professor, University Hospital Bordeaux, France
  • Study Chair: Antoine BENARD, MD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimated)

July 2, 2009

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2009/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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