Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders

Trigger Finger Clinical Trial

— SECOIA  

Official title:

Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045157
• Other study ID #: CHD21_0024
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: Agnès Dorion
• Phone: 251446380
• Email: agnes.dorion[@]chd-vendee.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion. Histological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection. If the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed. Surgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance). Percutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia. The hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient = 18 years old,
• Presence of a trigger finger (thumb or long fingers) to be treated
• Quinnell score >1
• Episode of trigger characterized on questioning or clinical examination
• Failure of a first corticosteroid infiltration > 3 months before inclusion
• First infiltration within 15 months of inclusion
• Thickening A1 pulley on ultrasound = 0.5 mm
• Patient who has the capacity to understand the protocol and has given consent to participate in the research,
• Patient with social security coverage

Exclusion Criteria:

• Presence of several symptomatic fingers requiring treatment by ultrasound-guided section of the pulley
• Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion
• Known allergy to corticoid (Hydrocortancyl®) including its excipients ((benzyl alcohol, sodium carmellose, sodium chloride, polysorbate 80)
• Known allergies to lidocaine
• Ongoing anticoagulant treatments (AVK, New Oral Anti-Coagulants)
• Local or general infection, or suspicion of infection
• Live vaccines
• Evolving viruses (hepatitis, herpes, varicella, shingles)
• Severe or uncontrolled hypertension
• Unbalanced diabetes
• Underlying progressive cardiovascular disease
• Hemodialysis patients
• Prosthesis on the finger to be treated
• Echographic tendon fissure
• Inflammatory disease (rheumatoid arthritis, spondyloarthritis, connective tissue diseases, etc.) with tenosynovitis.
• History of surgery on the fingers
• Dupuytren's disease
• Patient participating in another interventional clinical research protocol involving a drug or medical device
• Patient under guardianship, curators or legal protection

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

Procedure:
• Percutaneous A1 Pulley Release Under Ultrasound Guidance
the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.

Drug:
• Corticosteroid injection
corticosteroid injection is performed

Locations

Country	Name	City	State
France	Hopital Henri Mondor	Créteil
France	CHD Vendée	La Roche Sur Yon 9
France	CHU Nantes	Nantes
France	Hopital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms	Trigger finger's symptoms defined by a clinical Quinnell score =1 without the use of an alternative therapy	1 year postoperatively