NCT03583151

Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: J&M Shuler · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stenosing Tenosynovitis

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic fluid injection	Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair.
BIOLOGICAL	Steroid injection	Solu-medrol

Timeline

• Start date: 2018-05-10
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2018-07-11
• Last updated: 2018-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study