Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients
<p>Abstract</p> <p>Background</p> <p>Minimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a no...
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| Format: | Article |
| Language: | English |
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BMC
2011-09-01
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| Series: | BMC Musculoskeletal Disorders |
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| Online Access: | http://www.biomedcentral.com/1471-2474/12/206 |
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| author | Miller Larry E Repantis Thomas Korovessis Panagiotis Block Jon E |
| author_facet | Miller Larry E Repantis Thomas Korovessis Panagiotis Block Jon E |
| author_sort | Miller Larry E |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Minimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation.</p> <p>Methods</p> <p>Forty-two vertebral fractures were identified in 26 consecutive patients (mean age 74 ± 9 years). All patients were treated with a novel percutaneous vertebral augmentation device (Kiva<sup>® </sup>VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA). Indications for surgery included recent (≤ 3 months) symptomatic osteoporotic vertebral fracture (n = 34) and pathologic vertebral fractures (e.g. metabolic bone disease, myeloma, metastasis) (n = 8) located between T10 and S1. Patient outcomes were evaluated pre-treatment and at 2- and 6-month follow-up visits. Postoperative cement extravasation was assessed with computed tomography. Patient-reported back pain was quantified using an 11-point numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index on a 0 to 100% scale.</p> <p>Results</p> <p>No cases of intraoperative hypotension, respiratory disturbance, neurological deterioration, infection, or death were observed. There were 2 (4.8%) levels where anterior cement leakage was visible radiographically in patients with osteolyses. No intracanal leakage was observed. Back pain scores improved 71% (p < 0.001) from pre-treatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001).</p> <p>Conclusions</p> <p>The initial clinical experience with the Kiva<sup>® </sup>System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.</p> |
| first_indexed | 2024-12-11T05:24:17Z |
| format | Article |
| id | doaj.art-887c7ab4bec044f4b7b16a80d66a0310 |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-12-11T05:24:17Z |
| publishDate | 2011-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-887c7ab4bec044f4b7b16a80d66a03102022-12-22T01:19:37ZengBMCBMC Musculoskeletal Disorders1471-24742011-09-0112120610.1186/1471-2474-12-206Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patientsMiller Larry ERepantis ThomasKorovessis PanagiotisBlock Jon E<p>Abstract</p> <p>Background</p> <p>Minimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation.</p> <p>Methods</p> <p>Forty-two vertebral fractures were identified in 26 consecutive patients (mean age 74 ± 9 years). All patients were treated with a novel percutaneous vertebral augmentation device (Kiva<sup>® </sup>VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA). Indications for surgery included recent (≤ 3 months) symptomatic osteoporotic vertebral fracture (n = 34) and pathologic vertebral fractures (e.g. metabolic bone disease, myeloma, metastasis) (n = 8) located between T10 and S1. Patient outcomes were evaluated pre-treatment and at 2- and 6-month follow-up visits. Postoperative cement extravasation was assessed with computed tomography. Patient-reported back pain was quantified using an 11-point numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index on a 0 to 100% scale.</p> <p>Results</p> <p>No cases of intraoperative hypotension, respiratory disturbance, neurological deterioration, infection, or death were observed. There were 2 (4.8%) levels where anterior cement leakage was visible radiographically in patients with osteolyses. No intracanal leakage was observed. Back pain scores improved 71% (p < 0.001) from pre-treatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001).</p> <p>Conclusions</p> <p>The initial clinical experience with the Kiva<sup>® </sup>System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.</p>http://www.biomedcentral.com/1471-2474/12/206FractureMinimally invasiveOsteoporosisVertebral augmentation |
| spellingShingle | Miller Larry E Repantis Thomas Korovessis Panagiotis Block Jon E Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients BMC Musculoskeletal Disorders Fracture Minimally invasive Osteoporosis Vertebral augmentation |
| title | Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients |
| title_full | Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients |
| title_fullStr | Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients |
| title_full_unstemmed | Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients |
| title_short | Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients |
| title_sort | initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures a case series of 26 consecutive patients |
| topic | Fracture Minimally invasive Osteoporosis Vertebral augmentation |
| url | http://www.biomedcentral.com/1471-2474/12/206 |
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