VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

C. Klazen; H. Verhaar; L. Lampmann; J. Juttmann; M. Blonk; F. Jansen; A. Tielbeek; M. Schoemaker; E. Buskens; Y. van der Graaf; X. Janssens; H. Fransen; K. van Everdingen; A. Muller; W. Mali; P. Lohle

doi:10.1186/1745-6215-8-33

VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

C. Klazen, H. Verhaar, L. Lampmann, J. Juttmann, M. Blonk, F. Jansen, A. Tielbeek, M. Schoemaker, E. Buskens, Y. van der Graaf, X. Janssens, H. Fransen, K. van Everdingen, A. Muller, W. Mali, P. Lohle

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Abstract

Background: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published.

Objective: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality.

Materials and methods: The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. Conclusion: The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF.

Original language	English
Article number	33
Number of pages	5
Journal	TRIALS
Volume	8
DOIs	https://doi.org/10.1186/1745-6215-8-33
Publication status	Published - 31-Oct-2007

Keywords

QUALITY-OF-LIFE
LOW-BACK-PAIN
FOLLOW-UP
NATURAL-HISTORY
IMPROVEMENT
OUTCOMES

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Klazen, C., Verhaar, H., Lampmann, L., Juttmann, J., Blonk, M., Jansen, F., Tielbeek, A., Schoemaker, M., Buskens, E., van der Graaf, Y., Janssens, X., Fransen, H., van Everdingen, K., Muller, A., Mali, W., & Lohle, P. (2007). VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial. TRIALS, 8, [33]. https://doi.org/10.1186/1745-6215-8-33

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title = "VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial",

abstract = "Background: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published.Objective: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality.Materials and methods: The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. Conclusion: The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF.",

keywords = "QUALITY-OF-LIFE, LOW-BACK-PAIN, FOLLOW-UP, NATURAL-HISTORY, IMPROVEMENT, OUTCOMES",

author = "C. Klazen and H. Verhaar and L. Lampmann and J. Juttmann and M. Blonk and F. Jansen and A. Tielbeek and M. Schoemaker and E. Buskens and {van der Graaf}, Y. and X. Janssens and H. Fransen and {van Everdingen}, K. and A. Muller and W. Mali and P. Lohle",

year = "2007",

month = oct,

day = "31",

doi = "10.1186/1745-6215-8-33",

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Klazen, C, Verhaar, H, Lampmann, L, Juttmann, J, Blonk, M, Jansen, F, Tielbeek, A, Schoemaker, M, Buskens, E, van der Graaf, Y, Janssens, X, Fransen, H, van Everdingen, K, Muller, A, Mali, W & Lohle, P 2007, 'VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial', TRIALS, vol. 8, 33. https://doi.org/10.1186/1745-6215-8-33

VERTOS II : Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial. / Klazen, C.; Verhaar, H.; Lampmann, L. et al.

In: TRIALS, Vol. 8, 33, 31.10.2007.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - VERTOS II

T2 - Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

AU - Klazen, C.

AU - Verhaar, H.

AU - Lampmann, L.

AU - Juttmann, J.

AU - Blonk, M.

AU - Jansen, F.

AU - Tielbeek, A.

AU - Schoemaker, M.

AU - Buskens, E.

AU - van der Graaf, Y.

AU - Janssens, X.

AU - Fransen, H.

AU - van Everdingen, K.

AU - Muller, A.

AU - Mali, W.

AU - Lohle, P.

PY - 2007/10/31

Y1 - 2007/10/31

N2 - Background: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published.Objective: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality.Materials and methods: The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. Conclusion: The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF.

AB - Background: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published.Objective: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality.Materials and methods: The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded. Conclusion: The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF.

KW - QUALITY-OF-LIFE

KW - LOW-BACK-PAIN

KW - FOLLOW-UP

KW - NATURAL-HISTORY

KW - IMPROVEMENT

KW - OUTCOMES

U2 - 10.1186/1745-6215-8-33

DO - 10.1186/1745-6215-8-33

M3 - Article

SN - 1745-6215

VL - 8

JO - TRIALS

JF - TRIALS

M1 - 33

ER -