NCT01486420

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

3.8 years

First QC Date

December 1, 2011

Last Update Submit

October 27, 2015

Conditions

Keywords

Quinell gradeOpen surgerycorticosteroid injectionsrandomized controlled trialTrigger finger

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 COMPARATOR
Procedure: Open surgery

Corticosteroid Injection

ACTIVE COMPARATOR
Procedure: Corticosteroid injections

Interventions

Corticosteroid injections in and around A1-pulley.

Corticosteroid Injection
Open surgeryPROCEDURE

Open A1-pulley release

Open surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Center for Planned surgery - Regionalhospital Silkeborg

Silkeborg, 8600, Denmark

Location

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.

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jeppe Lange, M.D.

    Center for Planned Surgery - Regionalhospital Silkeborg

    STUDY DIRECTOR

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

Locations