RecruitingNot ApplicableNCT04533217

Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.

Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.


Sponsor

Spine Centre of Southern Denmark

Enrollment

90 participants

Start Date

Mar 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • known multiple myeloma
  • verified lesion(s) between Th6-L5
  • or less fractures
  • relevant pain in 3 months or less
  • vertebroplasty can be performed in one procedure
  • VAS 5 or more

Exclusion Criteria2

  • presence of neurologic deficit
  • psychological or psychiatric disorder hat is expected to interfere with compliance

Interventions

PROCEDUREVertebroplasty

Injection of cement into vertebral lesion(s)


Locations(1)

Center for Spine Surgery and Research

Middelfart, Region Syddanmark, Denmark

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NCT04533217


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