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

NCT05045157 — Not applicable, Active not recruiting, 50 participants, Centre Hospitalier Departemental Vendee

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05045157, acronym SECOIA
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	50 (Actual)
Sponsor	Centre Hospitalier Departemental Vendee (Other)
Conditions	Trigger Finger
Interventions	Percutaneous A1 Pulley Release Under Ultrasound Guidance, Corticosteroid injection (Procedure, drug)
Dates	start 2022-05-31, primary completion 2026-05-31, completion 2027-05-31 (estimated), first posted 2021-09-16, last updated 2026-06-02
Locations	4 sites in France

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
percutaneous A1 pulley release with corticosteroid injection	Experimental	Procedure: Percutaneous A1 Pulley Release Under Ultrasound Guidance; Drug: Corticosteroid injection
corticosteroid injection alone	Active comparator	Drug: Corticosteroid injection

Percutaneous A1 Pulley Release Under Ultrasound Guidance (Procedure): the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.
Corticosteroid injection (Drug): corticosteroid injection is performed

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country
Hopital Henri Mondor	Créteil	France
CHD Vendée	La Roche-sur-Yon	France
CHU Nantes	Nantes	France
Hopital Lariboisière	Paris	France

+Investigators

Grégoire Cormier, Dr, Principal investigator, CHD Vendée