Please select the eligibility criteria that correspond to the clinical trial below.
Title: VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures
Brief Summary: Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published.

Design:

This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy.

Study population:

Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score \&lt; -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging

Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm.

Economic evaluation:

Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared.

Time schedule:

The total study will take 36 months

Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.


Options:
A: Inclusion criteria:

* age: 50 and older
* vertebral fracture: 15-85% height loss
* level: thoracic vertebral body 5 (Th 5) or lower
* osteopenia (T-score \&lt; -1 SD)
* back pain for at least no longer than 6 weeks
* edema in the vertebrae on MR imaging

Exclusion criteria:

* complete loss of vertebral body height
* fracture through or destruction of the posterior vertebral wall
* pressure of bone fragments on the spinal cord
* osteomyelitis or spondylodiscitis
* vertebral column neoplasms
* uncorrectable coagulation disorder
* medical conditions that would make the patient ineligible for emergency decompressive surgery should it be necessary to treat a complication of the procedure
B: Inclusion Criteria:

* VCF on X-ray of the spine (minimal 15% loss of height)
* level of VCF Th5 or lower
* back pain ≤ 6 weeks at time of X-ray
* ≥ 50 years of age
* bone edema on MRI of the fractured vertebral body
* focal tenderness on VCF level
* decreased bone density T-scores ≤ -1

Exclusion Criteria:

* severe cardio-pulmonary condition
* untreatable coagulopathy
* systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
* suspected alternative underlying disease (malignancy)
* radicular and/or cauda compression syndrome
* contra-indication for MRI
C: Inclusion Criteria/Exclusion Criteria:

* Patient is greater than 60 years of age.
* Patient has pain which is not adequately controlled by oral analgesia or which has required hospitalisation and prevents early mobilisation
* Patient has pain from one or two compression fractures of the vertebrae in the areas T4 to L5 confirmed with a sagittal STIR (short tau inversion recovery) and sagittal T1 weighted MRI scan of the spine. Patients with three or more recent fractures are excluded.
* Clinical history verifies that patient's fracture occurred in the previous 6 weeks.
* Patient does not have a known coagulopathy. If on warfarin, the INR should be less than 2.5 within the last three days.
* Patient has no contraindications for conscious sedation.
* Patient reports pain during ambulation or movement from the compression fracture(s) of at least seven (7) out of ten (10) on a numerical pain scale.
* Patient has access to a telephone.
* Patient speaks English well enough to answer all health questions via telephone.
* Patient has a confirmed diagnosis of osteoporosis via a BMD within 6 months of baseline or a QCT at baseline.
* Patient does not have a history of debilitating chronic back pain which requires regular analgesia.
* Patients with chronic back pain who regularly use medication containing any narcotic for a period greater than 6 weeks, that is prior to the acute fracture.
* Patient does not have significant retropulsed fragment or spinal canal compromise of greater than 20% by retropulsed fragment.
* Patient has no mental incapacity or dementia that makes him/her unable to give informed consent.
* Patient has no history of vertebral osteomyelitis.
* Patient has vertebral body collapse not greater than 60% relative to closest intact vertebra.
* Patient has no pedicle fractures.
* Patient has no active local or systemic infection.
* Patient has not had surgery (within the last 60 days).
* Patient has no concomitant hip fracture.
* Patient has no malignant tumour deposit (multiple myeloma), tumour mass, or tumour extension into the epidural space at the level of the fracture to be treated on MRI.
* Patient does not have severely immunocompromised health status (including any patient who is HIV positive, currently on chemotherapy, taking high doses of long term corticosteroids - defined as a dose of prednisone exceeding 10mg for greater than 3 months in the last 12 months, has a hematologic malignancy, or a transplant recipient.)
* Patient able to attend face to face visits.
D: Inclusion Criteria:

* Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
* Fragility; i.e. fracture not in relation with significant trauma
* Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion Criteria:

* No vertebral edema on STIR MR images
* Uncorrectable bleeding diatheses
* Active infection
* Substantial retropulsion of bony fragments
* Non-osteoporotic fracture
* Concomitant neoplasm

Answer: A