Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders
SECOIA
1 other identifier
interventional
90
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedStudy Start
First participant enrolled
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
September 23, 2025
September 1, 2025
4 years
September 7, 2021
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
percutaneous A1 pulley release with corticosteroid injection
EXPERIMENTALcorticosteroid injection alone
ACTIVE COMPARATORInterventions
the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.
corticosteroid injection is performed
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Presence of several symptomatic fingers requiring treatment by ultrasound-guided section of the pulley
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hopital Henri Mondor
Créteil, 94000, France
CHD Vendée
La Roche-sur-Yon, 85925, France
CHU Nantes
Nantes, 44000, France
Hopital Lariboisière
Paris, 75010, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grégoire Cormier, Dr
CHD Vendée
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 16, 2021
Study Start
May 31, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share