title: Prospective randomized feasibility trial to assess the use of rhPDGF-BB in treatment of distal radius fractures.
abstract: BACKGROUND
  Recombinant human platelet-derived growth factor BB (rhPDGF-BB) combined with an osteoconductive scaffold (β-TCP) has been demonstrated to increase bone formation, but rhPDGF-BB has not been studied in human fractures. The purpose of this study was to evaluate the safety and potential use of locally administered rhPDGF-BB/β-TCP (Augment®) in acute wrist fractures.
  
  
  METHODS
  Forty patients with unstable distal radial fracture were randomized to closed reduction and external fixation alone (n = 20) or combined with injection of rhPDGF-BB/β-TCP (Augment®) into the fracture (n = 20). All patients were followed for 24 weeks. Outcome was based on adverse events, fracture displacement on radiographs, fracture healing, range of motion, grip strength, pain, and the disability of the arm, shoulder and hand (DASH) score.
  
  
  RESULTS
  There were no serious adverse events in the study, but the pin tract infection rate was significantly lower in the Augment® group. There was no difference between the groups in fracture healing time, based on number of healed cortices or fracture displacement. The Augment® group had an early temporary significant decrease in wrist flexion, but no difference in range of motion at 24 weeks. There were no differences between the two treatment groups for any other outcome variables.
  
  
  CONCLUSIONS
  rhPDGF-BB/β-TCP (Augment®) is safe and convenient for local administration into wrist fractures. In this pilot study, we could not detect any reduced healing time in the Augment® group although potential efficacy should be addressed in larger studies.
  
  
  BACKGROUND
  The clinical trial registration number for the study protocol is BMPI-2014-02-E.
authors.affiliation: Department of Orthopedics, Uppsala University, Sjukhusvägen 1, 751 85, Uppsala, Sweden. albert.christersson@akademiska.se.
authors.forename: Albert
authors.initials: A
authors.lastname: Christersson
authors.affiliation: Department of Orthopedics, Uppsala University, Sjukhusvägen 1, 751 85, Uppsala, Sweden. bengt.sanden@akademiska.se.
authors.forename: Bengt
authors.initials: B
authors.lastname: Sandén
authors.affiliation: Department of Orthopedics, Uppsala University, Sjukhusvägen 1, 751 85, Uppsala, Sweden. sune.larsson@akademiska.se.
authors.forename: Sune
authors.initials: S
authors.lastname: Larsson
mesh_terms: D000368:Aged; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010982:Platelet-Derived Growth Factor / Q000627:therapeutic use*; D011446:Prospective Studies; D011885:Radius Fractures / Q000628:therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D010982:Platelet-Derived Growth Factor; D011994:Recombinant Proteins