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

Not Applicable

Recruiting

• Conditions: Trigger Finger
• Interventions: Procedure: Percutaneous A1 Pulley Release Under Ultrasound Guidance; Drug: Corticosteroid injection

• Registration Number: NCT05045157
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Study Start: 2022-05-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous A1 pulley release with corticosteroid injection	Percutaneous A1 Pulley Release Under Ultrasound Guidance	-
percutaneous A1 pulley release with corticosteroid injection	Corticosteroid injection	-
corticosteroid injection alone	Corticosteroid injection	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms	1 year postoperatively	Trigger finger's symptoms defined by a clinical Quinnell score ≤1 without the use of an alternative therapy

Trial Locations

Locations (4)

Hopital Henri Mondor; 🇫🇷 Créteil, France

CHD Vendée; 🇫🇷 La Roche Sur Yon 9, France

CHU Nantes; 🇫🇷 Nantes, France

Hopital Lariboisière; 🇫🇷 Paris, France