title: Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized study.
abstract: METHODS
  Clinical randomized study.
  
  
  OBJECTIVE
  Percutaneous vertebroplasty is compared to conservative treatment in patients with acute or subacute osteoporotic vertebral fractures with respect to pain, physical and mental outcomes. The risk of vertebral fractures adjacent to treated levels is assessed.
  
  
  BACKGROUND
  There are some disagreements of the benefits of PVP for the treatment of acute osteoporotic vertebral fractures, but the long-term clinical outcome of PVP compared to conservative treatment has not been evaluated in a randomized study.
  
  
  METHODS
  The 3-months follow-up of this study has been published previously, and here we report the completed 12-months analysis. About 50 patients (41 females) were included from January 2001 until January 2008. Patients with vertebral fractures less than 8 weeks old were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale. Physical and mental outcomes were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 and 12 months.
  
  
  RESULTS
  Pain score before and after the operation in the PVP group was 7.9 and 2.0, respectively. There was no difference between the groups concerning pain at the 3- and 12-months follow-up. Supplementary assessment of back pain 1 month after discharge from hospital showed a significant lower VAS score in the PVP group over the conservative group. In the study period, 2 adjacent fractures in the PVP group and no adjacent fractures in the conservative group were registered.
  
  
  CONCLUSIONS
  PVP is a good treatment for some patients with acute/subacute painful osteoporotic vertebral fractures, but the majority of fractures will heal after 8 to 12 weeks of conservative treatment with subsequent decline in pain. The risk of new fractures needs further research.
authors.affiliation: Spine Section, Department of Orthopaedics, University Hospital of Odense, Odense, Denmark. rikke.rousing@ouh.regionsyddanmark.dk
authors.forename: Rikke
authors.initials: R
authors.lastname: Rousing
authors.forename: Karina L
authors.initials: KL
authors.lastname: Hansen
authors.forename: Mikkel O
authors.initials: MO
authors.lastname: Andersen
authors.forename: Stig M
authors.initials: SM
authors.lastname: Jespersen
authors.forename: Karsten
authors.initials: K
authors.lastname: Thomsen
authors.forename: Jens M
authors.initials: JM
authors.lastname: Lauritsen
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D008159:Lumbar Vertebrae / Q000293:injuries / Q000601:surgery*; D008297:Male; D010024:Osteoporosis / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D010146:Pain / Q000000981:diagnostic imaging; D059408:Pain Management; D010147:Pain Measurement; D017060:Patient Satisfaction; D018579:Patient Selection; D011788:Quality of Life; D011859:Radiography; D012720:Severity of Illness Index; D016103:Spinal Fractures / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D011795:Surveys and Questionnaires; D013904:Thoracic Vertebrae / Q000293:injuries / Q000601:surgery*; D016896:Treatment Outcome; D054854:Vertebroplasty