Table 16:
Summary of Clinical Studies Evaluating the Effectiveness of Vertebral Augmentation for High-Risk Vertebral Compression Fractures
| Author, Year Country |
Report Type | Study Recruitment Period |
Patients, N (F, M) Age, Mean ± SD (Range)a |
Operator Interventions and Treated Spinal Levels |
Study Objective Follow-Upb |
|---|---|---|---|---|---|
| Vertebroplasty for Spinal Fractures With Neurological Symptoms or Spinal Canal and/or Posterior Wall Compromise | |||||
| Alvarez et al, 2003123 Spain |
Single-site retrospective study, consecutive cases | April 1996 to February 2002 | 21 patients (14 F, 7 M) Primary malignancies Lung (n = 4), gastrointestinal stromaI (n = 3), renal (n = 3), breast (n = 3), prostate (n = 2), uterine (n = 1), other (n = 5) 58 years (27–78) |
Interventional neuroradiology VP at 27 VB levels (T, L) |
Treatment effectiveness, procedural outcomes, and quality of life |
| Appel et al, 2004124 United States |
Single-site retrospective study | June 9 to July 1, 2002 | 23 patients (NR) Cancers (primary malignancy NR) (n = 7); osteoporosis (n = 16) |
Interventional radiology 23 patients (7 with cancer) from 288 patients in 350 VP sessions at 686 VB levels |
Treatment safety and effectiveness of VP with spinal cord compromise |
| Basile et al, 2011115 Italy |
Single-site prospective study | January 2007 to January 2010 | 24 patients (13 F, 11 M) Primary malignancy Multiple myeloma (n = 24) 54.7 years (42–67) |
Interventional radiology VP at 34 VB levels (16 T, 18 L) |
Treatment safety with VP and delayed cement infusion with osteolysis or fracture of posterior wall |
| Georgy et al, 2009118 United States |
Single-site retrospective study, consecutive cases | NR | 37 patients (21 F, 16 M) Primary malignancies Breast (n = 9), lung (n = 6), multiple myeloma (n = 6), other (n = 16) Range 34–89 years |
Interventional radiology RFA (Cavity Spine Wand) and VP at 44 VB levels and KP at 14 VB levels |
Technical outcomes and safety of RFA and VA, VP or KP |
| Hentschel et al, 2004129 United States |
Case report | August 2001 | 1 patient (F) Primary malignancy Renal cell carcinoma and thymic cancer 60-year-old |
Neurosurgery VP at T7 |
Treatment safety and effectiveness of VP for vertebra plana VCF with cord compression |
| Li et al, 2013121 Gu et al, 2014135 China |
Single-site comparative cohort study | October 2009 to June 2012 | 52 of 63 patients (18 F, 34 M) Primary malignancies Lung (n = 27), liver (n = 5), thymic (n = 5), colon (n = 3), prostate (n = 3), breast (n = 2), multiple myeloma (n = 2), other (n = 5) 59.6 years (37–90) |
Interventional radiology VP at 94 VB levels |
Treatment safety and effectiveness of VP compared to VP and ITR in patients with VCFs and neurological symptoms of cord compression Mean 11 ± 6.3 months (VP + ITR) Mean 14.3 ± 6.7 months (VP) |
| Mazumdar et al, 2010125 United States |
Case reports | NR | 2 patients (1 F, 1 M) Primary malignancies Breast cancer (n = 1), multiple myeloma (n = 1) 71-year-old (F), 60-year-old (M) |
Interventional radiology VP at L4 and L3 VB levels |
Treatment effectiveness for VCF and radicular symptoms of pain and lower-extremity weakness |
| Prologo et al, 2013119 United States |
Single-site retrospective study | September 2007 to September 2012 | 15 patients (8 F, 7 M) Primary malignancies Lung (n = 4), breast (n = 3), prostate (n = 2), other (n = 6) 67.8 ± 15.3 years |
Interventional radiology RFA and VP at 15 VB levels (3 T, 12 L) |
Treatment feasibility, safety, and effectiveness of RFA (Cavity Spine Wand) and VP for VCFs with and without epidural involvement |
| Saliou et al, 2010131 France |
Single-site retrospective study | 1990 to 2006 | 51 of 508 consecutive patients (22 F, 29 M) Primary malignancies Breast (n = 8), lung (n = 8), kidney (n = 7), multiple myeloma (n = 5), plasmacytoma (n = 3), bladder (n = 4), other (n = 16) 62.5 years (28–85) |
Interventional neuroradiology VP at 74 VB levels |
Treatment feasibility, safety, and effectiveness of VP for malignant spine fractures with epidural involvement To 5 years |
| Shimony et al, 2004130 United States |
Single-site prospective comparative study | June 1998 to April 2002 | 50 of 277 patients (25 F, 25 M) Primary malignancies Multiple myeloma (n = 14), lung (n = 13), breast (n = 8), prostate (n = 3), lymphoma (n = 3), other (n = 9) Epidural involvement Group 1, none (n = 14), Group 2, mild (n = 18), Group 3, moderate (n = 18) 62.7 ± 14 years |
Interventional radiology VP in 60 sessions at 129 VB levels (T1 to L5) VP performed at one level (n = 14), two levels (n = 16), three levels (n = 10), four levels (n = 3), five levels (n = 2), six levels (n = 4), seven levels (n = 1) |
Treatment safety and effectiveness of VP with malignant compression fractures and epidural involvement To 2 years; median 3 months; 45 patients died during follow-up |
| Sun et al, 2011132, 2014126 China | Single-site retrospective study, consecutive cases | March 2000 to May 2012 | 43 patients (24 F, 19 M) Primary malignancies Lung (n = 13), breast (n = 12), kidney (n = 5), stomach (n = 4), bladder (n = 3), uterine (n = 3), colon (n = 2), ovary (n = 1) Epidural involvement Group 1 none (n = 25 levels); Group 2, mild (n = 23 levels); Group 3 moderate (n = 21 levels) 64.1 years (34–84) |
Interventional radiology VP at 69 VB levels (T3 to L5) |
Treatment safety and effectiveness of VP for painful spinal metastases with epidural encroachment 12 months |
| Trumm et al, 2012127 Germany |
Single-site retrospective study | December 2001 to June 2009 | 202 patients (116 F, 86 M) Primary malignancies Breast (n = 68), multiple myeloma (n = 40), lung (n = 22), renal (n = 10), prostate (n = 8), leukemia/lymphoma (n = 7), sarcoma (n = 6), pancreas (n = 5), thyroid (n = 4), other (n = 32) 63.2 ± 8.6 years |
Interventional radiology VP in 231 sessions at 331 VB levels VP performed at one level (n = 140), two levels (n = 82), three levels (n = 9) |
Technical procedure and treatment safety and effectiveness of VP with primary CT-fluoroscopic guidance for painful malignant vertebral osteolytes with and without fractures, and with and without epidural involvement |
| Van der Linden et al, 2007120 Netherlands |
Single-site retrospective study | July 2003 to December 2005 | 12 patients (4 F, 8 M) Primary malignancies Renal (n = 4), breast (n = 2), lung (n = 2), multiple myeloma (n = 2), B-cell lymphoma (n = 1), chondrosarcoma (n = 1) 57 years (31–79) |
Interventional radiology and orthopedic surgery RFA and VP at 12 VB levels (6 L, 4 T, 2 C) |
Treatment safety and effectiveness of RFA (RITA and Cool-tip) and VP in patients with posterior vertebral wall defects, with and without spinal canal involvement 3 months; 4 patients died during follow-up |
| Woo et al, 2013128 Korea |
Case report | NR | 1 patient (M) Cholangiocarcinoma 52-year-old |
Anaesthesiology VP at L4 |
Treatment effectiveness and safety of VP for spinal metastases and radicular pain due to metastatic compression of dorsal root ganglion resistant to multiple spinal injection blocks |
| Kyphoplasty or Kyphoplasty and Vertebroplasty for Spinal Fractures With Neurological Symptoms or Spinal Cord and/or or Posterior Wall Compromise | |||||
| Dalbayrak et al, 2010133 Turkey |
Single-site retrospective review | NR | 31 patients (17 F, 14 M) Primary malignancies Gastric (n = 7), breast (n = 6), lung (n = 4), multiple myeloma (n = 6), other (n = 8) 62 years (35–78) |
Neurosurgery KP at 39 VB levels (T or L) |
Procedural and treatment safety and effectiveness Follow-up NR; half with epidural involvement |
| Eleraky et al, 2011122 United States |
Single-site retrospective study | NR | 14 of 23 patients (6 F, 8 M) Primary malignancies Multiple myeloma (n = 6), lung (n = 3), breast (n = 2), other (n = 3) 62 years (41–71) |
Neurosurgery KP at 30 VB levels (T1 to T5) |
Treatment effectiveness of KP for upper thoracic VCFs Mean 16 months; minimum 1 year |
| Hentschel et al, 2005116 United States |
Single-site consecutive comparative registry review | January 2001 to July 2003 | 66 patients (32 F, 34 M) Group 1 (no contraindication) 49 patients (24 F, 25 M) Primary malignancies Multiple myeloma (n = 24), metastases (n = 8), hemangioma (n = 2) osteoporosis (n = 15) Median 64 years (29–88) Group 2 (contraindication) 17 patients (8 F, 9 M) Primary malignancies Multiple myeloma (n = 11), metastases (n = 5), hemangioma (n = 0); osteoporosis (n = 1) Median 61 years (42–75) |
Interventional radiology Group 1 (no contraindication) VP at 89 VB levels KP at 22 VB levels Group 2 (contraindication) VP at 13 VB levels KP at 5 VB levels |
Comparative treatment safety and effectiveness of VP or KP in groups with contraindicated conditions and those with conventional criteria |
| Knight et al, 2008117 Canada |
Case series | NR | 3 patients (3 F) Primary malignancies Breast (n = 1), lung (n = 1), multiple myeloma (n = 1) 32-year-old, 59-year-old, 67-year-old |
Interventional radiology KP at T9 VP at T6 VP at T9 |
Effectiveness of spinal cement augmentation under C-arm CT guidance with spinal column narrowing |
| Lim et al, 2011134 Korea |
Case report | NR | 1 patient (F) Primary malignancy Gastric cancer and cholangiocarcinoma 76-year-old |
Anaesthesiology KP at T12 and L1 |
Treatment safety and effectiveness of KP with VCF with large vertebral bony defect and neurological symptoms |
Abbreviations: CT, computed tomography; F, female; ITR, interventional tumour removal; KP, kyphoplasty; L, lumbar; M, male; NR, not reported; RFA, radiofrequency ablation; SD, standard deviation; T, thoracic; VB, vertebral body; VCF, vertebral compression fracture; VP, vertebroplasty.
a
Unless otherwise indicated.
b
If reported in study.