Surgical Release of Ai Pulley Trigger Finger Clinical Trial
Official title:
Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
| Verified date | February 2020 |
| Source | National and Kapodistrian University of Athens |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 1, 2016 |
| Est. primary completion date | October 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National and Kapodistrian University of Athens |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Resolution of triggering expressed as the "success rate" per digit. | 12 weeks | ||
| Secondary | The time for taking postoperative pain killers | 12 weeks | ||
| Secondary | Range of motion recovery | 12 weeks | ||
| Secondary | QuickDASH test scores (Greek version) | 12 weeks | ||
| Secondary | Time to return to normal activities (including work) | 12 weeks | ||
| Secondary | Cosmetic results | 12 weeks |