- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02830672
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
February 25, 2020 updated by: Vasileios S. Nikolaou, National and Kapodistrian University of Athens
Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open surgical release A1 Pulley
|
|
Active Comparator: Ultrasound guided close release A1 pulley
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of triggering expressed as the "success rate" per digit.
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time for taking postoperative pain killers
Time Frame: 12 weeks
|
12 weeks
|
Range of motion recovery
Time Frame: 12 weeks
|
12 weeks
|
QuickDASH test scores (Greek version)
Time Frame: 12 weeks
|
12 weeks
|
Time to return to normal activities (including work)
Time Frame: 12 weeks
|
12 weeks
|
Cosmetic results
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 6, 2016
First Submitted That Met QC Criteria
July 9, 2016
First Posted (Estimate)
July 13, 2016
Study Record Updates
Last Update Posted (Actual)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgical Release of Ai Pulley Trigger Finger
-
Assiut UniversityCompletedUS-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge NeedleEgypt
-
Police General Hospital, ThailandCompletedPostoperative Pain | Trigger Finger | Percutaneous A1 Pulley Release | Steroid InjectionThailand
-
Eslam Elsayed Ali ShohdaNot yet recruitingTrigger Finger | Validity of Palpation
-
Cairo UniversityCompletedTrigger Finger DisorderEgypt
-
The Cleveland ClinicCompletedAmyloidosis | Transthyretin Amyloidosis | Trigger Finger | Primary Amyloidosis of Light Chain TypeUnited States
-
Odense University HospitalOdense Patient Data Explorative NetworkRecruitingToe Joint Deformity | Clubfoot | Flatfoot | Trigger Finger | Syndactyly | Hand Deformities, Congenital | Tarsal Coalition | Congenital Talipes Equinovarus | Valgus Foot Deformity | Club Foot | Polydactyly Toe | Thumb Hypoplasia | Polydactyly; Fingers | Osteomyelitis of Hindfoot | Osteomyelitis of Midfoot | Congenital Talipes... and other conditionsDenmark