Overview

This trial is active, not recruiting.

Condition surgical release of ai pulley trigger finger
Treatment surgical release a1 pulley for trigger finger of the hand
Phase phase 2/phase 3
Sponsor National and Kapodistrian University of Athens
Start date November 2015
End date August 2016
Trial size 60 participants
Trial identifier NCT02830672, 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
surgical release a1 pulley for trigger finger of the hand
(Active Comparator)
surgical release a1 pulley for trigger finger of the hand

Primary Outcomes

Measure
Resolution of triggering expressed as the "success rate" per digit.
time frame: 12 weeks

Secondary Outcomes

Measure
The time for taking postoperative pain killers
time frame: 12 weeks
Range of motion recovery
time frame: 12 weeks
QuickDASH test scores (Greek version)
time frame: 12 weeks
Time to return to normal activities (including work)
time frame: 12 weeks
Cosmetic results
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by National and Kapodistrian University of Athens.