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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

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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, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg.

In: BIOMED RES INT , 2015, p. UNSP 927813.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Noriega, D, Krüger, A, Ardura, F, Hansen-Algenstaedt, N, Hassel, F, Barreau, X & Beyerlein, J 2015, 'Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study', BIOMED RES INT , pp. UNSP 927813. https://doi.org/10.1155/2015/927813

APA

Noriega, D., Krüger, A., Ardura, F., Hansen-Algenstaedt, N., Hassel, F., Barreau, X., & Beyerlein, J. (2015). Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study. BIOMED RES INT , UNSP 927813. https://doi.org/10.1155/2015/927813

Vancouver

Noriega D, Krüger A, Ardura F, Hansen-Algenstaedt N, Hassel F, Barreau X et al. Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study. BIOMED RES INT . 2015;UNSP 927813. https://doi.org/10.1155/2015/927813

Bibtex

@article{014a8c937b40428b9ca675a6ac8e87db,
title = "Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study",
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.",
keywords = "Aged, Aged, 80 and over, Bone Cements, Female, Fractures, Compression, Humans, Male, Middle Aged, Orthopedic Procedures, Pain Measurement, Pain, Postoperative, Prospective Studies, Prostheses and Implants, Prosthesis Design, Quality of Life, Spinal Fractures, Treatment Outcome",
author = "David Noriega and Antonio Kr{\"u}ger and Francisco Ardura and Nils Hansen-Algenstaedt and Frank Hassel and Xavier Barreau and J{\"o}rg Beyerlein",
year = "2015",
doi = "10.1155/2015/927813",
language = "English",
pages = "UNSP 927813",
journal = "BIOMED RES INT ",
issn = "2314-6133",
publisher = "Hindawi Publishing Corporation",

}

RIS

TY - JOUR

T1 - Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study

AU - Noriega, David

AU - Krüger, Antonio

AU - Ardura, Francisco

AU - Hansen-Algenstaedt, Nils

AU - Hassel, Frank

AU - Barreau, Xavier

AU - Beyerlein, Jörg

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Bone Cements

KW - Female

KW - Fractures, Compression

KW - Humans

KW - Male

KW - Middle Aged

KW - Orthopedic Procedures

KW - Pain Measurement

KW - Pain, Postoperative

KW - Prospective Studies

KW - Prostheses and Implants

KW - Prosthesis Design

KW - Quality of Life

KW - Spinal Fractures

KW - Treatment Outcome

U2 - 10.1155/2015/927813

DO - 10.1155/2015/927813

M3 - SCORING: Journal article

C2 - 25667929

SP - UNSP 927813

JO - BIOMED RES INT

JF - BIOMED RES INT

SN - 2314-6133

ER -