Percutaneous Vertebroplasty Compared to Conservative Treatment in Patients With Painful Acute or Subacute Osteoporotic Vertebral Fractures: Three-Months Follow-Up in a Clinical Randomized Study

Spine (Phila Pa 1976). 2009 Jun 1;34(13):1349-54. doi: 10.1097/BRS.0b013e3181a4e628.

Abstract

Study design: Clinical randomized study.

Objective: The aim of this study is to compare percutaneous vertebroplasty (PVP) to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomized study with respect to pain, physical and mental outcome, and to asses the risk of adjacent fractures.

Summary of background data: PVP is a therapeutic procedure performed to reduce pain in vertebral lesions. Despite the lack of comparative randomized clinical trials PVP is generally seen as a safe and efficient procedure for painful osteoporotic fractures.

Methods: Fifty patients (41 females) were included from January 2001 until January 2008. Patients with acute (<2 weeks) and subacute (between 2 and 8 weeks) osteoporotic fractures were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale and physical and mental outcome were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 months.

Results: Reduction in pain from initial visit to 3-month follow-up was comparable in the 2 groups (P = 0.33) from approximate visual analogue scale 8.0 to visual analogue scale 2.0, intragroup difference was significant (P = 0.00). Reduction in pain in the PVP group was immediate 12 to 24 hours after the procedure (P = 0.00). There was no significant difference in the other parameters when comparing the results at inclusion and after 3 months within both groups and between the groups after 3 months with a few exceptions. We observed 2 adjacent fractures in the PVP group and non in the conservative group.

Conclusion: The majority of patients with acute or subacute painful osteoporotic compression fractures in the spine will recover after a few months of conservative treatment. The risk of adjacent fractures needs further research. No major adverse events were observed.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Orthopedic Procedures / methods
  • Osteoporosis / complications*
  • Pain / etiology
  • Pain / physiopathology
  • Pain / surgery*
  • Pain Measurement
  • Spinal Fractures / etiology
  • Spinal Fractures / surgery*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Vertebroplasty / methods