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:

* 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
B: * \> or = 50 years of age
* Compression fracture (T4-L5)within previous 12 mo.
* Pain from compression fracture
* No malignant tumor
* No back surgery
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:

* 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

Answer: D