Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
1 other identifier
interventional
166
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 6, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 28, 2015
October 1, 2015
3.8 years
December 1, 2011
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quinell grade
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.
12 months
Secondary Outcomes (2)
Numerical Rating Scale (NRS) score
12 weeks
infection
12 weeks
Study Arms (2)
Open surgery
ACTIVE COMPARATORCorticosteroid Injection
ACTIVE COMPARATORInterventions
Corticosteroid injections in and around A1-pulley.
Eligibility Criteria
You may qualify if:
- Trigger finger Quinell grade IIb-V in digit I-V
You may not qualify if:
- Former treatment of Trigger finger in affected digit
- Dupuytrens contracture in affected digit
- Allergies or intolerance to used medications
- Rheumatoid Arthritis
- Insulin dependent Diabetes Mellitus
- Amyloidosis
- Mucopolysaccharidosis
- Already included in study with another digit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jeppe Lange, MDlead
Study Sites (1)
Center for Planned surgery - Regionalhospital Silkeborg
Silkeborg, 8600, Denmark
Related Publications (1)
Hansen RL, Lange J. Surgery versus ultrasound-guided steroid injections for trigger finger disease: protocol of a randomized controlled trial. Dan Med J. 2013 May;60(5):A4633.
PMID: 23673265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeppe Lange, M.D.
Center for Planned Surgery - Regionalhospital Silkeborg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior project superviser
Study Record Dates
First Submitted
December 1, 2011
First Posted
December 6, 2011
Study Start
January 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 28, 2015
Record last verified: 2015-10