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Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

NCT03583151 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vivex Biomedical

    collaborator UNKNOWN

  • J&M Shuler

    lead INDUSTRY

Principal Investigators

  • Michael Shuler, MD · Athens Orthopedic Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2018-12-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583151 on ClinicalTrials.gov