drugset / Trial / NCT01129583

Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness

NCT01129583 ↗

Completed 18 enrolled Columbia University Allergan · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.

Timeline

Start
2003-11
Primary completion
2009-09
Completion
2010-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Botulinum Toxin vs Saline; p = 0.06; t-test, 2 sided NCT01129583 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 200 iu Intramuscular

Indications

No indication recorded.