title: Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial.
abstract: BACKGROUND
  Non-randomised trials have reported benefits of kyphoplasty in patients with cancer and vertebral compression fractures (VCFs). We aimed to assess the efficacy and safety of balloon kyphoplasty compared with non-surgical management for patients with cancer who have painful VCFs.
  
  
  METHODS
  The Cancer Patient Fracture Evaluation (CAFE) study was a randomised controlled trial at 22 sites in Europe, the USA, Canada, and Australia. We enrolled patients aged at least 21 years who had cancer and one to three painful VCFs. Patients were randomly assigned by a computer-generated minimisation randomisation algorithm to kyphoplasty or non-surgical management (control group). Investigators and patients were not masked to treatment allocation. The primary endpoint was back-specific functional status measured by the Roland-Morris disability questionnaire (RDQ) score at 1 month. Outcomes at 1 month were analysed by modified intention to treat, including all patients with data available at baseline and at 1 month follow-up. Patients in the control group were allowed to crossover to receive kyphoplasty after 1 month. This study is registered with ClinicalTrials.gov, NCT00211237.
  
  
  RESULTS
  Between May 16, 2005, and March 11, 2008, 134 patients were enrolled and randomly assigned to kyphoplasty (n=70) or non-surgical management (n=64). 65 patients in the kyphoplasty group and 52 in the control group had data available at 1 month. The mean RDQ score in the kyphoplasty group changed from 17·6 at baseline to 9·1 at 1 month (mean change -8·3 points, 95% CI -6·4 to -10·2; p<0·0001). The mean score in the control group changed from 18·2 to 18·0 (mean change 0·1 points; 95% CI -0·8 to 1·0; p=0·83). At 1 month, the kyphoplasty treatment effect for RDQ was -8·4 points (95% CI -7·6 to -9·2; p<0·0001). The most common adverse events within the first month were back pain (four of 70 in the kyphoplasty group and five of 64 in the control group) and symptomatic vertebral fracture (two and three, respectively). One patient in the kyphoplasty group had an intraoperative non-Q-wave myocardial infarction, which resolved and was attributed to anaesthesia. Another patient in this group had a new VCF, which was thought to be device related.
  
  
  CONCLUSIONS
  For painful VCFs in patients with cancer, kyphoplasty is an effective and safe treatment that rapidly reduces pain and improves function.
  
  
  BACKGROUND
  Medtronic Spine LLC.
authors.affiliation: Institute for Myeloma and Bone Cancer Research, West Hollywood, CA 90069, USA. jberenson@imbcr.org
authors.forename: James
authors.initials: J
authors.lastname: Berenson
authors.forename: Robert
authors.initials: R
authors.lastname: Pflugmacher
authors.forename: Peter
authors.initials: P
authors.lastname: Jarzem
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Zonder
authors.forename: Kenneth
authors.initials: K
authors.lastname: Schechtman
authors.forename: John B
authors.initials: JB
authors.lastname: Tillman
authors.forename: Leonard
authors.initials: L
authors.lastname: Bastian
authors.forename: Talat
authors.initials: T
authors.lastname: Ashraf
authors.forename: Frank
authors.initials: F
authors.lastname: Vrionis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D050815:Fractures, Compression / Q000209:etiology / Q000601:surgery* / Q000628:therapy; D006801:Humans; D058498:Kyphoplasty; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000628:therapy; D010146:Pain / Q000209:etiology; D016103:Spinal Fractures / Q000209:etiology / Q000601:surgery* / Q000628:therapy; D016896:Treatment Outcome