Prospective study of standalone balloon kyphoplasty with calcium phosphate cement augmentation in traumatic fractures

Abstract

Prospective consecutive series cases study to investigate the clinical and radiological results of standalone balloon kyphoplasty and cement augmentation with calcium phosphate in traumatic fractures. Independent observer evaluation of radiological and computer tomography results, visual analogue scale (VAS), Roland-Morris score and complications with acute traumatic compression fractures type A, treated with a standalone balloon kyphoplasty and cement augmentation with calcium phosphate (Calcibon TM ); follow-up time at a mean of 30 months (24-37 months). From August 2002 to August 2003, consecutive patients with traumatic compression fractures (Magerl type A) without neurological deficit underwent standalone kyphoplasty with Calcibon. We report here the pre-, post-operative and the followup results, applying the VAS (0-10) for pain rating, the Roland-Morris (0-24) disability score, CT-scan examination, detailed radiographic evaluation of vertebral body (VB) deformity and segmental kyphosis measurement. The pre-operative X-ray measurements, VAS and the 7 days Roland-Morris scores are compared with the post-operative and the 30 months follow-up findings. Twenty-eight patients with 33 treated fracture levels were included in this study. The mean initial vertebral deformity (VB kyphosis) was 17°, corrected to a post-operative of 6°. We noted a loss of correction at the follow-up in comparison to the post-operative standing X-ray at 24 h of 3°ver-tebral deformity and 3°segmental kyphosis. The VAS score demonstrates a decrease over time from a mean of 8.7-3.1 at 7 days and to 0.8 at the last follow-up. The Roland-Morris disability score demonstrates a similar improvement. We noticed no major complications related to the procedure. The mean cement resorption after 1 year was 20.3% (0.3-35.3%) and is related to the individual biological resorption process and is not predictable. All patients with vertebral fractures as sole medical problem were discharged within 48 h. All active patients returned to the same work within 3 months with the same working ability as before the accident. Standalone balloon kyphoplasty is a potential alternative mini-invasive technique to reduce the fractures. However, due to the intrinsic characteristic of calcium phosphate cement (Calcibon) we recommend the application of this biological cement for standalone reduction and stabilisation only in fractures type A1 and A3.1 in young patient. In case of higher destruction levels of the VB, we propose the utilisation of Calcibon associated with posterior instrumentation. Having regard to the pointed out indications, our preliminary results demonstrate a new possibility to treat this kind of fractures, allowing a rapid handling of pain, early discharge and return to normal activities.

Percutaneous kyphoplasty and pedicle screw fixation for the management of thoraco-lumbar burst fractures

“…The development of new minimal invasive strategies can be therefore an interesting alternative for the treatment of burst fractures and the results of a recent prospective study [6] with standalone balloon kyphoplasty showed satisfactory outcomes, especially for A3.1 fractures.…”

“…1) was measured on the sagittal reconstructions, using two indices: first by comparing the height of the anterior face of the fractured vertebral body with that of the adjacent body both pre-and post-operatively, as described by Acosta [10]; and secondly, using the Beck index, as described by Maestretti [6], to compare the height of the anterior face of the fractured vertebral body with that of the posterior face of the same body. The presence of any local segmental vertebral kyphosis was checked both before and after surgery.…”

“…This two-stage procedure considerably lengthens the patients' hospital stay and increases the surgical risks involved, especially for patients with co-morbidities. On the other hand, recent development of percutaneous techniques to stabilize the vertebral body with cement have emerged and have been used alone in association with posterior osteosynthesis for traumatic lesions with good outcomes [6][7][8][9].…”

Minimally invasive spine surgery in the treatment of thoracolumbar and lumbar spine trauma

“…Maestretti et al used percutaneous augmentation with CPC alone without posterior stabilization in the treatment of thoracolumbar compression and burst fractures. 25 Inclusion criteria included fracture with at least 15° of kyphosis in patients with a single traumatic injury or 10° in those with more than one traumatic injury or with multilevel fractures without any neurological deficit. The authors reported good outcomes with a standalone procedure both clinically and radiographically.…”

A survey of the “surgical and research” articles in the European Spine Journal, 2007

“…The paper by Maestretti et al [30] in which a calcium phosphate material is used, with the hope that it will in time be replaced with bone, certainly demonstrates a very effective clinical success, and it is certainly an attractive technique in the multiply injured patient. However, clearly at 3 years, it is not converted to bone, and one must be concerned at the presence of a foreign body, with somewhat unsatisfactory mechanical properties compared with bone, yet occupying a significant part of the vertebral body in some one who may be young.…”