A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)
Condition: Osteoporosis; Vertebral Fracture
MeSH terms: Osteoporosis; Fractures, Bone; Spinal Fractures
Study type: Interventional

Summary: 
      Background The standard care in patients with a painful osteoporotic vertebral compression
      fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally
      invasive technique, is a relatively new treatment option. Recent randomized controlled trials
      (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while
      an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in
      patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs
      defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of
      patients still had disabling pain after 3 months or longer. These patients with sustained
      pain after 3 months may benefit from PV.

      Objective To compare pain relief after PV with a sham intervention in selected patients with
      a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria
      as in VERTOS II an IV. Secondary outcome measures are back pain related disability and
      quality of life.

      Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint.
      Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture
      level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS)
      score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age
      50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed.
      Follow-up is at regular intervals during one year period with VAS score for pain as primary
      endpoint. Secondary endpoints are back pain related disability and quality of life measured
      with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and
      physical function measured with the Roland Morris Disability questionnaire.

      Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of
      vertebroplasty in patients with sustained pain 3 months or longer after a vertebral
      compression fracture.
    


Intervention name(s): percutaneous vertebroplasty; Sham procedure
Intervention type(s): Device; Procedure
Intervention description(s): Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine. For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.; Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the methacrylate monomer (PMMA) is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.
Other intervention name(s): § 888.302713 Polymethylmethacrylate (PMMA) Bone Cement.
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment