NCT02196233

Brief Summary

Trigger finger is a condition commonly treated with surgical intervention, yet no specific incision type has been associated with improved or worsened scar quality or outcome. Therefore, the investigators objective is to determine if the incision type may affect the results of operative treatment of trigger finger. Therefore, the goals of this study are as follows: Primary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release with scar quality and patient satisfaction via a validated scar evaluation scale. Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release to patient outcome via a validated upper extremity outcome score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

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

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

6.7 years

First QC Date

July 17, 2014

Last Update Submit

August 16, 2019

Conditions

Trigger Finger

Keywords

Trigger FingerProspective Clinical ResearchRandomizedQuestionnairesTransverseLongitudinal

Outcome Measures

Primary Outcomes (1)

  • Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale

    1 Year Follow-up

Secondary Outcomes (1)

  • Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score

    1 Year Follow-up

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over the age of 18 presenting to the four attending surgeons with Trigger Finger

You may qualify if:

  • Patients who fail conservative treatment and elect to proceed with open surgical release of the A1 pulley will be offered the option of being included in the study.

You may not qualify if:

  • Patients aged less than 18, previous failed surgical A1 pulley release, and patients receiving their care outside of the University of Utah Hospital system or the Veteran Affairs Hospital
  • In addition, this study will evaluate trigger finger release; patients receiving treatment for trigger thumb will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (15)

  • Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.

    PMID: 11476534BACKGROUND

  • Ryzewicz M, Wolf JM. Trigger digits: principles, management, and complications. J Hand Surg Am. 2006 Jan;31(1):135-46. doi: 10.1016/j.jhsa.2005.10.013.

    PMID: 16443118BACKGROUND

  • Sato ES, Gomes Dos Santos JB, Belloti JC, Albertoni WM, Faloppa F. Treatment of trigger finger: randomized clinical trial comparing the methods of corticosteroid injection, percutaneous release and open surgery. Rheumatology (Oxford). 2012 Jan;51(1):93-9. doi: 10.1093/rheumatology/ker315. Epub 2011 Oct 29.

    PMID: 22039269BACKGROUND

  • Stefanich RJ, Peimer CA. Longitudinal incision for trigger finger release. J Hand Surg Am. 1989 Mar;14(2 Pt 1):316-7. doi: 10.1016/0363-5023(89)90030-0. No abstract available.

    PMID: 2703681BACKGROUND

  • Turowski GA, Zdankiewicz PD, Thomson JG. The results of surgical treatment of trigger finger. J Hand Surg Am. 1997 Jan;22(1):145-9. doi: 10.1016/S0363-5023(05)80195-9.

    PMID: 9018628BACKGROUND

  • Froimson, AI. Tenosynovitis and Tennis Elbow; in Green's Operative Hand Surgery, 3rd Edition.

    BACKGROUND

  • Bonnici AV, Spencer JD. A survey of 'trigger finger' in adults. J Hand Surg Br. 1988 May;13(2):202-3. doi: 10.1016/0266-7681_88_90139-8.

    PMID: 3385301BACKGROUND

  • Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. No abstract available.

    PMID: 20808746BACKGROUND

  • Brown E, Genoway KA. Impact of diabetes on outcomes in hand surgery. J Hand Surg Am. 2011 Dec;36(12):2067-72. doi: 10.1016/j.jhsa.2011.10.002.

    PMID: 22123050BACKGROUND

  • Koh S, Nakamura S, Hattori T, Hirata H. Trigger digits in diabetes: their incidence and characteristics. J Hand Surg Eur Vol. 2010 May;35(4):302-5. doi: 10.1177/1753193409341103. Epub 2009 Aug 17.

    PMID: 19687073BACKGROUND

  • Griggs SM, Weiss AP, Lane LB, Schwenker C, Akelman E, Sachar K. Treatment of trigger finger in patients with diabetes mellitus. J Hand Surg Am. 1995 Sep;20(5):787-9. doi: 10.1016/S0363-5023(05)80432-0.

    PMID: 8522745BACKGROUND

  • Lim MH, Lim KK, Rasheed MZ, Narayanan S, Beng-Hoi Tan A. Outcome of open trigger digit release. J Hand Surg Eur Vol. 2007 Aug;32(4):457-9. doi: 10.1016/J.JHSB.2007.02.016. Epub 2007 May 4.

    PMID: 17482325BACKGROUND

  • Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complications. 1997 Sep-Oct;11(5):287-90. doi: 10.1016/s1056-8727(96)00076-1.

    PMID: 9334911BACKGROUND

  • van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.

    PMID: 16079683BACKGROUND

  • van der Wal MB, Verhaegen PD, Middelkoop E, van Zuijlen PP. A clinimetric overview of scar assessment scales. J Burn Care Res. 2012 Mar-Apr;33(2):e79-87. doi: 10.1097/BCR.0b013e318239f5dd.

    PMID: 22249102BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Douglas Hutchinson

    Orthopedic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 21, 2014

Study Start

November 1, 2012

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

US(1)