Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial

Dennis Carli; Alexander Venmans; Paul Lodder; Esther Donga; Thijs van Oudheusden; Issam Boukrab; Kees Schoemaker; Albert Smeets; Catharina Schonenberg; Joshua Hirsch; Jolanda de Vries; Paul Lohle

doi:10.1148/radiol.222535

Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial

Dennis Carli, Alexander Venmans, Paul Lodder, Esther Donga, Thijs van Oudheusden, Issam Boukrab, Kees Schoemaker, Albert Smeets, Catharina Schonenberg, Joshua Hirsch, Jolanda de Vries, Paul Lohle

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

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Abstract

Background

Evidence regarding percutaneous vertebroplasty (PV) for chronic painful osteoporotic vertebral compression fractures (OVCFs) remains limited.

Purpose

To compare pain relief, quality of life, and disability between PV and active control (anesthetic infiltration) interventions for chronic OVCF.

Materials and Methods

This prospective randomized clinical trial was conducted between May 2013 and June 2019 in participants with pain due to OVCF lasting longer than 3 months with bone marrow edema present at MRI. Study participants were randomly assigned to undergo PV ( n = 40) or active control intervention ( n = 40). The primary outcome was pain severity, assessed with the visual analog scale (VAS) (range, 0-10) during 12 months after treatment. Secondary outcomes included Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) score (range, 0-100) and Roland Morris Disability Questionnaire (RMDQ) score (range, 0-100). Outcomes were analyzed according to a longitudinal multilevel model used to test the difference between groups in change from baseline across follow-up.

Results

The mean age of the 80 participants (54 women) was 69 years ± 10 (SD) in the PV group and 71 years ± 10 in the active control group. VAS score was 7.6 (95% CI: 7.0, 8.2) in the PV group and 7.3 (95% CI: 6.9, 7.8) in the active control group at baseline ( P = .47) and 3.9 (95% CI: 3.1, 4.8) and 5.1 (95% CI: 4.3, 6.0), respectively, at month 12 ( P = .045). At month 12, the group difference from baseline was 1.3 (95% CI: 0.1, 2.6; P = .02) for VAS, 5.2 (95% CI: 0.9, 9.4; P = .02) for QUALEFFO, and 7.1 (95% CI: -3.3, 17.5; P = .18) for RMDQ, favoring the PV group.

Conclusion

In the treatment of pain caused by chronic OVCFs, PV is more effective for pain relief and quality of life improvement than anesthetic injection alone, with similar improvement for disability between the groups.

Original language	English
Article number	e222535
Number of pages	10
Journal	Radiology
Volume	308
Issue number	1
DOIs	https://doi.org/10.1148/radiol.222535
Publication status	Published - 2023

Keywords

Fractures, Compression/diagnostic imaging
Quality of Life
Prospective Studies
Spinal Fractures/diagnostic imaging
Bone Cements/therapeutic use
Osteoporotic Fractures/diagnostic imaging
Osteoporosis
Pain/etiology
Vertebroplasty/adverse effects
Treatment Outcome

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10.1148/radiol.222535

Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trialFinal published version, 778 KBLicence: Taverne

Cite this

Carli, D., Venmans, A., Lodder, P., Donga, E., van Oudheusden, T., Boukrab, I., Schoemaker, K., Smeets, A., Schonenberg, C., Hirsch, J., de Vries, J., & Lohle, P. (2023). Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial. Radiology, 308(1), Article e222535. https://doi.org/10.1148/radiol.222535

@article{0d05b070ca6a49c98ef21982bc09b51a,

title = "Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial",

abstract = "Background Evidence regarding percutaneous vertebroplasty (PV) for chronic painful osteoporotic vertebral compression fractures (OVCFs) remains limited. Purpose To compare pain relief, quality of life, and disability between PV and active control (anesthetic infiltration) interventions for chronic OVCF. Materials and Methods This prospective randomized clinical trial was conducted between May 2013 and June 2019 in participants with pain due to OVCF lasting longer than 3 months with bone marrow edema present at MRI. Study participants were randomly assigned to undergo PV ( n = 40) or active control intervention ( n = 40). The primary outcome was pain severity, assessed with the visual analog scale (VAS) (range, 0-10) during 12 months after treatment. Secondary outcomes included Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) score (range, 0-100) and Roland Morris Disability Questionnaire (RMDQ) score (range, 0-100). Outcomes were analyzed according to a longitudinal multilevel model used to test the difference between groups in change from baseline across follow-up. Results The mean age of the 80 participants (54 women) was 69 years ± 10 (SD) in the PV group and 71 years ± 10 in the active control group. VAS score was 7.6 (95% CI: 7.0, 8.2) in the PV group and 7.3 (95% CI: 6.9, 7.8) in the active control group at baseline ( P = .47) and 3.9 (95% CI: 3.1, 4.8) and 5.1 (95% CI: 4.3, 6.0), respectively, at month 12 ( P = .045). At month 12, the group difference from baseline was 1.3 (95% CI: 0.1, 2.6; P = .02) for VAS, 5.2 (95% CI: 0.9, 9.4; P = .02) for QUALEFFO, and 7.1 (95% CI: -3.3, 17.5; P = .18) for RMDQ, favoring the PV group. Conclusion In the treatment of pain caused by chronic OVCFs, PV is more effective for pain relief and quality of life improvement than anesthetic injection alone, with similar improvement for disability between the groups. ",

keywords = "Fractures, Compression/diagnostic imaging, Quality of Life, Prospective Studies, Spinal Fractures/diagnostic imaging, Bone Cements/therapeutic use, Osteoporotic Fractures/diagnostic imaging, Osteoporosis, Pain/etiology, Vertebroplasty/adverse effects, Treatment Outcome",

author = "Dennis Carli and Alexander Venmans and Paul Lodder and Esther Donga and {van Oudheusden}, Thijs and Issam Boukrab and Kees Schoemaker and Albert Smeets and Catharina Schonenberg and Joshua Hirsch and {de Vries}, Jolanda and Paul Lohle",

note = "Funding Information: Disclosures of conflicts of interest: D.C. No relevant relationships. A.V. Grants from Medtronic and Stryker. P. Lodder No relevant relationships. E.D. No relevant relationships. T.v.O. Grants from Medtronic and Stryker. I.B. No relevant relationships. K.S. No relevant relationships. A.S. No relevant relationships. C.S. Grants from Medtronic and Stryker. J.H. Grant from the Nei-man Health Policy Institute; consulting fees from Medtronic, AgNovos, and Relievant. J.d.V. No relevant relationships. P. Lohle Grants from Medtronic and Stryker. Publisher Copyright: {\textcopyright} RSNA, 2023.",

year = "2023",

doi = "10.1148/radiol.222535",

language = "English",

volume = "308",

journal = "Radiology",

issn = "0033-8419",

publisher = "Radiological Society of North America Inc.",

number = "1",

}

Carli, D, Venmans, A, Lodder, P, Donga, E, van Oudheusden, T, Boukrab, I, Schoemaker, K, Smeets, A, Schonenberg, C, Hirsch, J, de Vries, J & Lohle, P 2023, 'Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial', Radiology, vol. 308, no. 1, e222535. https://doi.org/10.1148/radiol.222535

TY - JOUR

T1 - Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures

T2 - The VERTOS V randomized controlled trial

AU - Carli, Dennis

AU - Venmans, Alexander

AU - Lodder, Paul

AU - Donga, Esther

AU - van Oudheusden, Thijs

AU - Boukrab, Issam

AU - Schoemaker, Kees

AU - Smeets, Albert

AU - Schonenberg, Catharina

AU - Hirsch, Joshua

AU - de Vries, Jolanda

AU - Lohle, Paul

N1 - Funding Information: Disclosures of conflicts of interest: D.C. No relevant relationships. A.V. Grants from Medtronic and Stryker. P. Lodder No relevant relationships. E.D. No relevant relationships. T.v.O. Grants from Medtronic and Stryker. I.B. No relevant relationships. K.S. No relevant relationships. A.S. No relevant relationships. C.S. Grants from Medtronic and Stryker. J.H. Grant from the Nei-man Health Policy Institute; consulting fees from Medtronic, AgNovos, and Relievant. J.d.V. No relevant relationships. P. Lohle Grants from Medtronic and Stryker. Publisher Copyright: © RSNA, 2023.

PY - 2023

Y1 - 2023

N2 - Background Evidence regarding percutaneous vertebroplasty (PV) for chronic painful osteoporotic vertebral compression fractures (OVCFs) remains limited. Purpose To compare pain relief, quality of life, and disability between PV and active control (anesthetic infiltration) interventions for chronic OVCF. Materials and Methods This prospective randomized clinical trial was conducted between May 2013 and June 2019 in participants with pain due to OVCF lasting longer than 3 months with bone marrow edema present at MRI. Study participants were randomly assigned to undergo PV ( n = 40) or active control intervention ( n = 40). The primary outcome was pain severity, assessed with the visual analog scale (VAS) (range, 0-10) during 12 months after treatment. Secondary outcomes included Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) score (range, 0-100) and Roland Morris Disability Questionnaire (RMDQ) score (range, 0-100). Outcomes were analyzed according to a longitudinal multilevel model used to test the difference between groups in change from baseline across follow-up. Results The mean age of the 80 participants (54 women) was 69 years ± 10 (SD) in the PV group and 71 years ± 10 in the active control group. VAS score was 7.6 (95% CI: 7.0, 8.2) in the PV group and 7.3 (95% CI: 6.9, 7.8) in the active control group at baseline ( P = .47) and 3.9 (95% CI: 3.1, 4.8) and 5.1 (95% CI: 4.3, 6.0), respectively, at month 12 ( P = .045). At month 12, the group difference from baseline was 1.3 (95% CI: 0.1, 2.6; P = .02) for VAS, 5.2 (95% CI: 0.9, 9.4; P = .02) for QUALEFFO, and 7.1 (95% CI: -3.3, 17.5; P = .18) for RMDQ, favoring the PV group. Conclusion In the treatment of pain caused by chronic OVCFs, PV is more effective for pain relief and quality of life improvement than anesthetic injection alone, with similar improvement for disability between the groups.

AB - Background Evidence regarding percutaneous vertebroplasty (PV) for chronic painful osteoporotic vertebral compression fractures (OVCFs) remains limited. Purpose To compare pain relief, quality of life, and disability between PV and active control (anesthetic infiltration) interventions for chronic OVCF. Materials and Methods This prospective randomized clinical trial was conducted between May 2013 and June 2019 in participants with pain due to OVCF lasting longer than 3 months with bone marrow edema present at MRI. Study participants were randomly assigned to undergo PV ( n = 40) or active control intervention ( n = 40). The primary outcome was pain severity, assessed with the visual analog scale (VAS) (range, 0-10) during 12 months after treatment. Secondary outcomes included Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) score (range, 0-100) and Roland Morris Disability Questionnaire (RMDQ) score (range, 0-100). Outcomes were analyzed according to a longitudinal multilevel model used to test the difference between groups in change from baseline across follow-up. Results The mean age of the 80 participants (54 women) was 69 years ± 10 (SD) in the PV group and 71 years ± 10 in the active control group. VAS score was 7.6 (95% CI: 7.0, 8.2) in the PV group and 7.3 (95% CI: 6.9, 7.8) in the active control group at baseline ( P = .47) and 3.9 (95% CI: 3.1, 4.8) and 5.1 (95% CI: 4.3, 6.0), respectively, at month 12 ( P = .045). At month 12, the group difference from baseline was 1.3 (95% CI: 0.1, 2.6; P = .02) for VAS, 5.2 (95% CI: 0.9, 9.4; P = .02) for QUALEFFO, and 7.1 (95% CI: -3.3, 17.5; P = .18) for RMDQ, favoring the PV group. Conclusion In the treatment of pain caused by chronic OVCFs, PV is more effective for pain relief and quality of life improvement than anesthetic injection alone, with similar improvement for disability between the groups.

KW - Fractures, Compression/diagnostic imaging

KW - Quality of Life

KW - Prospective Studies

KW - Spinal Fractures/diagnostic imaging

KW - Bone Cements/therapeutic use

KW - Osteoporotic Fractures/diagnostic imaging

KW - Osteoporosis

KW - Pain/etiology

KW - Vertebroplasty/adverse effects

KW - Treatment Outcome

UR - https://classic.clinicaltrials.gov/ct2/show/NCT01963039

UR - http://www.scopus.com/inward/record.url?scp=85165518584&partnerID=8YFLogxK

U2 - 10.1148/radiol.222535

DO - 10.1148/radiol.222535

M3 - Article

C2 - 37462495

SN - 0033-8419

VL - 308

JO - Radiology

JF - Radiology

IS - 1

M1 - e222535

ER -

Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial

Abstract

Keywords

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Research team calls for reintroduction of insured care for percutaneous vertebroplasty treatment for painful osteoporotic vertebral compression fractures

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Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures: The VERTOS V randomized controlled trial

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

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Research team calls for reintroduction of insured care for percutaneous vertebroplasty treatment for painful osteoporotic vertebral compression fractures

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