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

NCT00931333 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Vertebra Trauma

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Jean-Charles LE HUEC, Professor · University Hospital Bordeaux, France

  • Antoine BENARD, MD · University Hospital Bordeaux, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931333 on ClinicalTrials.gov