Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.|
- Quinell grade [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.
Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.
- Numerical Rating Scale (NRS) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)
- infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Infection occurence following either procedure
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Open surgery||
Procedure: Open surgery
Open A1-pulley release
|Active Comparator: Corticosteroid Injection||
Procedure: Corticosteroid injections
Corticosteroid injections in and around A1-pulley.
|Contact: Rehne L. Hansen, M.D.||+45 87 22 21 firstname.lastname@example.org|
|Contact: Jeppe Lange, M.D.||email@example.com|
|Center for Planned surgery - Regionalhospital Silkeborg||Recruiting|
|Silkeborg, Denmark, 8600|
|Contact: Soren Mikkelsen, M.D +45 87 22 24 64|
|Principal Investigator: Rehne L. Hansen, M.D.|
|Study Director:||Jeppe Lange, M.D.||Center for Planned Surgery - Regionalhospital Silkeborg|