drugset / Trial / NCT03583151

Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

NCT03583151

Phase 3 Unknown 100 enrolled J&M Shuler Vivex Biomedical · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.

Timeline

Start
2018-05-10
Primary completion
2018-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Amniotic Fluid Unknown 1 ml
Subject Methylprednisolone Other / unclassified 1 ml

Indications