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

Primary Purpose

Trigger Finger

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous A1 Pulley Release Under Ultrasound Guidance
Corticosteroid injection
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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- 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

Sites / Locations

  • Hopital Henri MondorRecruiting
  • CHD VendéeRecruiting
  • CHU NantesRecruiting
  • Hopital LariboisièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

percutaneous A1 pulley release with corticosteroid injection

corticosteroid injection alone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
September 27, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT05045157
Brief Title
Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
percutaneous A1 pulley release with corticosteroid injection
Arm Type
Experimental
Arm Title
corticosteroid injection alone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous A1 Pulley Release Under Ultrasound Guidance
Intervention Description
the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Intervention Description
corticosteroid injection is performed
Primary Outcome Measure Information:
Title
Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms
Description
Trigger finger's symptoms defined by a clinical Quinnell score ≤1 without the use of an alternative therapy
Time Frame
1 year postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Dorion
Phone
251446380
Ext
+33
Email
agnes.dorion@chd-vendee.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grégoire Cormier, Dr
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmi GROSS, Dr
Phone
149812711
Ext
+33
Email
jimmygross07@gmail.com
Facility Name
CHD Vendée
City
La Roche Sur Yon 9
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire CORMIER, Dr
Phone
251446197
Ext
+33
Email
gregoire.cormier@chd-vendee.fr
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît LE GOFF, Dr
Phone
240084824
Ext
+33
Email
Benoit.LEGOFF@chu-nantes.fr
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Maillet, Dr
Phone
149958631
Ext
+33
Email
maillet.jerem@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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