Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures
Brief Summary: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.


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:

* Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film
* Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old
* Pain not responsive to standard medical therapy
* Current rating for pain intensity of at least 3 on a scale of 0 to 10

Exclusion Criteria:

* Evidence or suspicion of malignant tumor or spinal canal compromise
* Concomitant hip fracture
* Local or systemic infection
* Uncorrectable bleeding diatheses
* Surgery within the previous 60 days
* Lack of access to telephone
* Inability to communicate in English
* Dementia
* Pregnancy
* Abnormal renal function or anticipated venography
* Conscious sedation is contraindicated for subject
C: 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
D: 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.

Answer: C