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Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

Noriega D, Krüger A, Ardura F, Hansen-Algenstaedt N, Hassel F, Barreau X, Beyerlein J - Biomed Res Int (2015)

Bottom Line: Statistically significant improvements were found regarding pain, function, and quality of life.The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively.No device- or surgery-related complications were found.

View Article: PubMed Central - PubMed

Affiliation: Spine-Unit, University Hospital Valladolid, 47008 Valladolid, Spain.

ABSTRACT
The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

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Related in: MedlinePlus

Details of patient recruitment and follow-up.
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Related In: Results  -  Collection


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fig1: Details of patient recruitment and follow-up.

Mentions: The patients were given information about the treatment and the follow-up program and signed an informed consent before enrolment. The data was collected at baseline, after 48–72 hours, or at discharge, at 6 and at 12 months. The primary endpoint was to determine the occurrence of cement leakages assessed by X-ray or CT scan. Among the secondary endpoints clinical outcome was measured by reported back pain, quality of life, functional capacity, and the safety of the SpineJack system. Details on patient recruitment and follow-up are given in Figure 1.


Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

Noriega D, Krüger A, Ardura F, Hansen-Algenstaedt N, Hassel F, Barreau X, Beyerlein J - Biomed Res Int (2015)

Details of patient recruitment and follow-up.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4309217&req=5

fig1: Details of patient recruitment and follow-up.
Mentions: The patients were given information about the treatment and the follow-up program and signed an informed consent before enrolment. The data was collected at baseline, after 48–72 hours, or at discharge, at 6 and at 12 months. The primary endpoint was to determine the occurrence of cement leakages assessed by X-ray or CT scan. Among the secondary endpoints clinical outcome was measured by reported back pain, quality of life, functional capacity, and the safety of the SpineJack system. Details on patient recruitment and follow-up are given in Figure 1.

Bottom Line: Statistically significant improvements were found regarding pain, function, and quality of life.The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively.No device- or surgery-related complications were found.

View Article: PubMed Central - PubMed

Affiliation: Spine-Unit, University Hospital Valladolid, 47008 Valladolid, Spain.

ABSTRACT
The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

Show MeSH
Related in: MedlinePlus