Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

NCT03583151 | Unknown Phase 3 FDA Drug

• 1 other identifier: Random TF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Patient reported pain level

  Analog pain scale (0-10)

  12 months

Secondary Outcomes (2)

• Trigger frequency

  12 months

• Disabilities of the Arm Shoulder and Hand score

  12 months

Study Arms (2)

Steroid injection

ACTIVE COMPARATOR

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

Biological: Steroid injection

Amniotic fluid injection

EXPERIMENTAL

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

Biological: Amniotic fluid injection

Interventions

Amniotic fluid injection 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.

Amniotic fluid injection

Steroid injection BIOLOGICAL

Solu-medrol

Steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• J&M Shuler: lead
• Vivex Biomedical: collaborator

Study Sites (1)

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Tendon Entrapment

Interventions

Steroids

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michael Shuler, MD

  Athens Orthopedic Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: May 10, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 11, 2018

Record last verified: 2018-06

Locations

US (1)