Prospective, Randomized, Multi-Center Feasibility Trial of rhPDGF-BB versus Autologous Bone Graft in a Foot and Ankle Fusion Model

  • Zanolli D
  • Nunley J
  • Easley M
 et al. 
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Abstract

BACKGROUND: In foot and ankle surgery, there are multiple sites used for autologous bone graft, including the proximal (PT) or distal tibia (DT), calcaneus (C), and iliac crest (ICBG). There has been no comparison between these anatomic areas and the potential for acute or persistent pain at 1 year. The purpose of this study was to prospectively compare patient-reported outcomes of acute and persistent pain at 1 year after surgery to determine if harvest site selection made a difference.

METHODS: As part of a clinical trial examining ankle and hindfoot fusion rates with autograft compared with synthetic graft, the autologous bone graft harvest sites were assessed with visual analog pain outcome scores at 3, 24, 36, and 52 weeks after surgery. Patients with a score of 20+ defined clinically significant pain. Four harvest sites were compared: ICBG, PT, DT, and C. Fisher exact test was used to compare the graft site pain between locations.

RESULTS: Twelve percent of subjects reported clinically significant pain at 24 weeks and 8.5% at 52 weeks postoperatively. Each lower extremity harvest site (C, DT, PT) showed higher rates of clinically significant graft harvest site pain than the ICBG at 52 weeks.

CONCLUSIONS: Autologous bone graft harvest carried a risk of persistent pain at up to 1 year (weeks 24-52) in 18% of patients. Lower-extremity bone graft sites had the greatest risk for persistent pain at 1 year.

LEVEL OF EVIDENCE: Level II, prospective comparative study.

Author-supplied keywords

  • Amputation
  • Ankle
  • Ankle Arthritis
  • Ankle Arthrodesis
  • Arthrodesis
  • Autogenous bone graft
  • Biofilm infection
  • Economics
  • Foot
  • Implant-associated orthopedic infections (IAOIs)
  • JBJS-A
  • Limb salvage
  • Prosthetic joint infection
  • Sonication
  • Statistical model
  • The Journal of Bone and Joint Surgery
  • angiography
  • ankle
  • ankle and hindfoot fusion
  • arthritis
  • arthrodesis
  • autologous bone
  • biosyn-
  • bone graft pain
  • charcot foot
  • computed tomography scan
  • diabetic foot imaging
  • emission tomography
  • factor
  • foot and ankle autologous graft
  • fusion
  • graft
  • imaging modality fre-
  • is also a diagnostic
  • myelitis
  • neuroarthropathy
  • osteo-
  • outcome
  • pet
  • recombinant platelet derived growth
  • subtalar
  • thetic bone graft substitute

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Authors

  • Diego H. Zanolli

  • James A. Nunley

  • Mark E. Easley

  • Laura Scorzolini

  • Miriam Lichtner

  • Marco Iannetta

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