title: Extracorporeal shock wave treatment of non- or delayed union of proximal metatarsal fractures.
abstract: BACKGROUND
  Nonunion or delayed union of fractures in the proximal aspect of metatarsals 1 to 4 and Zone 2 of the fifth metatarsal were treated by high energy extracorporeal shock wave treatment (ESWT) to study the safety and efficacy of this method of treatment in a FDA study of the Ossatron device.
  
  
  METHODS
  In a prospective single-arm, multi-center study, 34 fractures were treated in 32 patients (two subjects had two independent fractures) with ESWT. All fractures were at least 10 (range, 10 to 833) weeks after injury, with a median of 23 weeks. ESWT application was conducted using a protocol totaling 2,000 shocks for a total energy application of approximately 0.22 to 0.51 mJ/mm2 per treatment. The mean ESWT application time for each of the treatments was 24.6 +/- 16.6 minutes, and anesthesia time averaged 27.1 +/- 10.4 minutes. All subjects were followed for 1 year after treatment at intervals of 12 weeks, 6, 9, and 12 months.
  
  
  RESULTS
  The overall success rate at the 12-week visit was 71% with low complications, significant pain improvement as well as improvement on the SF-36. The success/fail criteria was evaluated again at the 6- and 12-month followup, showing treatment success rates of 89% (23/26) and 90% (18/20), respectively. The most common adverse event was swelling in the foot, reported by five subjects (15.6%).
  
  
  CONCLUSIONS
  High-energy ESWT appears to be effective and safe in patients for treatment of nonunion or a delayed healing of a proximal metatarsal, and in fifth metatarsal fractures in Zone 2.
authors: University of Tennessee College of Medicine, Orthopaedic Surgery, 975 East Third St, Hospital Box 287, Chattanooga, TN 37363, USA.
authors: Richard G
authors: RG
authors: Alvarez
authors: Brandon
authors: B
authors: Cincere
authors: Chandra
authors: C
authors: Channappa
authors: Richard
authors: R
authors: Langerman
authors: Robert
authors: R
authors: Schulte
authors: Juha
authors: J
authors: Jaakkola
authors: Keith
authors: K
authors: Melancon
authors: Michael
authors: M
authors: Shereff
authors: G Lee
authors: GL
authors: Cross
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D050723:Fractures, Bone / Q000628:therapy*; D005599:Fractures, Ununited / Q000628:therapy*; D006305:Health Status Indicators; D019220:High-Energy Shock Waves / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008682:Metatarsal Bones / Q000293:injuries*; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult