Trial | NCT03583151  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
Study Started
May 10
2018
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jul 11
2018

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

Steroid injection Active Comparator

1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine

Amniotic fluid injection Experimental

1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine

Criteria 

Inclusion Criteria:

Patient is at least 18 years of age
Patient is diagnosed with stenosing tenosynovitis

Exclusion Criteria:

Patient is less than 18 years of age
Pregnancy
Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.
No Results Posted