osteopenia - porous bone
Conditions
Interventions
Patients in the non-operative arm (amount: 80) will receive medical treatment
and other non-surgical treatments as back braces and physiotherapy.
Patients in the balloon kypholasty arm (amount:160) w
Sponsors
Hilversum Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Minimum of one and maximum of three painful, acute (edema present on MRI obtained within a one month period prior to enrolment) vertebral body compression fractures due to osteopenia arising from osteoporosis, multiple myeloma or osteolytic metastatic tumors. -Pre-treatment VAS score of 4 or more on scale 0 (no pain) - 10 (worst imaginable pain) -21 years of age or older -balloon kyphoplasty is technically feasible -a signed Informed constent has been obtained from the patient
Exclusion criteria
Exclusion criteria: -pedicle fractures -pre-existing neurological deficit or radicular pain -Spinal cord compression or canal compromise requiring decompression -Disabling back pain secondary to causes other than the fractures -pre-existing contraindications to surgery in general, to MRI or known allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in quality of life as measured by the EQ-5D at 7 days compared to at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Following variables will be compared to at baseline: Pain using the VAS score (at 7days, 6 weeks, 4 & 12 months), EQ-5D (at 6 weeks and 4 & 12 months), Qualeffo (at 6 weeks adn 12 months) and an economic questionnaire (at 4 & 12 months) | — |
Countries
Netherlands
Outcome results
None listed