title: Initial outcome and efficacy of "kyphoplasty" in the treatment of painful osteoporotic vertebral compression fractures.
abstract: METHODS
  An Institutional Review Board-approved Phase I efficacy study of inflatable bone tamp usage in the treatment of symptomatic osteoporotic compression fractures.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of inflatable bone tamp reduction and cement augmentation, "kyphoplasty," in the treatment of painful osteoporotic vertebral compression fractures.
  
  
  BACKGROUND
  Osteoporotic compression fractures can result in progressive kyphosis and chronic pain. Traditional treatment for these patients includes bed rest, analgesics, and bracing. Augmentation of vertebral compression fractures with polymethylmethacrylate, "vertebroplasty," has been used to treat pain. This technique, however, makes no attempt to restore the height of the collapsed vertebral body. Kyphoplasty is a new technique that involves the introduction of inflatable bone tamps into the vertebral body. Once inflated, the bone tamps restore the vertebral body back toward its original height while creating a cavity that can be filled with bone cement.
  
  
  METHODS
  Seventy consecutive kyphoplasty procedures were performed in 30 patients. The indications included painful primary or secondary osteoporotic vertebral compression fractures. Mean duration of symptoms was 5.9 months. Symptomatic levels were identified by correlating the clinical data with MRI findings. Perioperative variables and bone tamp complications or issues were recorded and analyzed. Preoperative and postoperative radiographs were compared to calculate the percentage height restored. Outcome data were obtained by comparing preoperative and latest postoperative SF-36 data.
  
  
  RESULTS
  At the completion of the Phase I study there were no major complications related directly to use of this technique or use of the inflatable bone tamp. In 70% of the vertebral bodies kyphoplasty restored 47% of the lost height. Cement leakage occurred at six levels (8.6%).SF-36 scores for Bodily Pain 11.6-58.7, (P = 0.0001) and Physical Function 11.7-47.4, (P = 0.002) were among those that showed significant improvement.
  
  
  CONCLUSIONS
  The inflatable bone tamp was efficacious in the treatment of osteoporotic vertebral compression fractures. Kyphoplasty is associated with early clinical improvement of pain and function as well as restoration of vertebral body height in the treatment of painful osteoporotic compression fractures.
authors.affiliation: Department of Orthopaedics, Cleveland Clinic Foundation, Cleveland, Ohio, USA. lieberi@ccf.org
authors.forename: I H
authors.initials: IH
authors.lastname: Lieberman
authors.forename: S
authors.initials: S
authors.lastname: Dudeney
authors.forename: M K
authors.initials: MK
authors.lastname: Reinhardt
authors.forename: G
authors.initials: G
authors.lastname: Bell
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001843:Bone Cements / Q000627:therapeutic use*; D015331:Cohort Studies; D005593:Fracture Fixation, Internal / Q000379:methods*; D005598:Fractures, Spontaneous / Q000209:etiology / Q000628:therapy; D006801:Humans; D007278:Injections, Spinal; D007738:Kyphosis / Q000209:etiology / Q000628:therapy*; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000628:therapy*; D019904:Polymethyl Methacrylate / Q000008:administration & dosage / Q000627:therapeutic use; D018434:Sickness Impact Profile; D016103:Spinal Fractures / Q000209:etiology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D001843:Bone Cements; D019904:Polymethyl Methacrylate