Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
Primary Purpose
Surgical Release of Ai Pulley Trigger Finger
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Surgical release A1 pulley for Trigger finger of the hand
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Release of Ai Pulley Trigger Finger
Eligibility Criteria
Inclusion Criteria:
- Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.
Exclusion Criteria:
- Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
- Patients with multiple trigger fingers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open surgical release A1 Pulley
Ultrasound guided close release A1 pulley
Arm Description
Outcomes
Primary Outcome Measures
Resolution of triggering expressed as the "success rate" per digit.
Secondary Outcome Measures
The time for taking postoperative pain killers
Range of motion recovery
QuickDASH test scores (Greek version)
Time to return to normal activities (including work)
Cosmetic results
Full Information
NCT ID
NCT02830672
First Posted
July 6, 2016
Last Updated
February 25, 2020
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT02830672
Brief Title
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
Official Title
Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
October 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Release of Ai Pulley Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open surgical release A1 Pulley
Arm Type
Active Comparator
Arm Title
Ultrasound guided close release A1 pulley
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Surgical release A1 pulley for Trigger finger of the hand
Primary Outcome Measure Information:
Title
Resolution of triggering expressed as the "success rate" per digit.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The time for taking postoperative pain killers
Time Frame
12 weeks
Title
Range of motion recovery
Time Frame
12 weeks
Title
QuickDASH test scores (Greek version)
Time Frame
12 weeks
Title
Time to return to normal activities (including work)
Time Frame
12 weeks
Title
Cosmetic results
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.
Exclusion Criteria:
Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
Patients with multiple trigger fingers
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
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