drugset / Trial / NCT01129583
Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 200 iu | Intramuscular |
Indications
No indication recorded.