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Preliminary Evaluation of a Thrombin-Related Peptide for Acceleration of Distal Radius Fracture Healing
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ABSTRACT
The effect of Chrysalin, a synthetic 23 amino acid thrombin precursor, on fracture repair acceleration was studied. This preliminary prospective, double blind, randomized study compared two doses (10 µg and 100 µg) of Chrysalin to placebo (saline), injected in distal radius fractures in 90 patients. Follow-up was weekly for 8 weeks, then at 3 and 6 months. Safety evaluation included reporting adverse events; efficacy was examined using blinded radiographic healing evaluation by the treating surgeon (investigator), orthopedic hand surgeon, and radiologist. No differences in safety parameters were seen.
The investigator’s evaluation of cortical bridging found significant healing acceleration in the low (10 µg) dose of Chrysalin compared to placebo. Median healing time was 24 days (10-µg dose) compared to 31 days (placebo) and 36 days (100-µg dose), a statistically significant difference (P=.0067). The radiologist assessed trabecular bridging as significantly accelerated in the 10-µg dose (P=.13). Time to event analysis showed Chrysalin-treated fractures healed earlier than placebo; extra-articular fractures healed at 4 weeks as assessed by the investigator (Fisher exact P=.039) and the independent hand surgeon (Fisher exact P=.014).
The results demonstrate safety and efficacy of Chrysalin on accelerated distal radius fracture healing and support initiation of a larger multicenter clinical trial.