Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

NCT ID: NCT03583151

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-10
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Steroid injection

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

Group Type: ACTIVE_COMPARATOR

Steroid injection

Intervention Type: BIOLOGICAL

Solu-medrol

Amniotic fluid injection

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

Group Type: EXPERIMENTAL

Amniotic fluid injection

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Steroid injection

Solu-medrol

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vivex Biomedical

UNKNOWN

Sponsor Role: collaborator

J&M Shuler

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Shuler, MD

Role: PRINCIPAL_INVESTIGATOR

Athens Orthopedic Clinic

Locations

Athens Orthopedic Clinic

Athens, Georgia, United States

Countries

United States

Other Identifiers

Random TF

Identifier Type: -

Identifier Source: org_study_id