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

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ClinicalTrials.gov Identifier: NCT05045157
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Study Description
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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


Condition or disease Intervention/treatment Phase
Trigger Finger Procedure: Percutaneous A1 Pulley Release Under Ultrasound Guidance Drug: Corticosteroid injection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: percutaneous A1 pulley release with corticosteroid injection 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
Active Comparator: corticosteroid injection alone Drug: Corticosteroid injection
corticosteroid injection is performed


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms [ Time Frame: 1 year postoperatively ]
    Trigger finger's symptoms defined by a clinical Quinnell score ≤1 without the use of an alternative therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05045157


Contacts
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Contact: Agnès Dorion 251446380 ext +33 agnes.dorion@chd-vendee.fr

Locations
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France
Hopital Henri Mondor Recruiting
Créteil, France, 94000
Contact: Jimmi GROSS, Dr    149812711 ext +33    jimmygross07@gmail.com   
CHD Vendée Recruiting
La Roche Sur Yon 9, France, 85925
Contact: Grégoire CORMIER, Dr    251446197 ext +33    gregoire.cormier@chd-vendee.fr   
CHU Nantes Recruiting
Nantes, France, 44000
Contact: Benoît LE GOFF, Dr    240084824 ext +33    Benoit.LEGOFF@chu-nantes.fr   
Hopital Lariboisière Recruiting
Paris, France, 75010
Contact: Jérémie Maillet, Dr    149958631 ext +33    maillet.jerem@gmail.com   
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Grégoire Cormier, Dr CHD Vendée
More Information
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT05045157    
Other Study ID Numbers: CHD21_0024
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases