Trigger Finger Clinical Trial
Official title:
A Prospective, Randomized Trial Evaluating the Type of Incision on Outcomes and Patient Satisfaction in the Surgical Treatment of Trigger Finger
| NCT number | NCT02196233 |
| Other study ID # | 60239 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | July 2019 |
| Verified date | August 2019 |
| Source | University of Utah |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | July 2019 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 95 Years |
| Eligibility |
Inclusion Criteria: - All patients over the age of 18 presenting to the four attending surgeons (Don Coleman, Douglas Hutchinson, Andrew Tyser, Angela Wang) through either the University of Utah Orthopaedic Center or the Veteran Affairs Hospital will be evaluated for possible inclusion into the study - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Utah | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| University of Utah |
United States,
Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. — View Citation
Bonnici AV, Spencer JD. A survey of 'trigger finger' in adults. J Hand Surg Br. 1988 May;13(2):202-3. — View Citation
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. Review. — View Citation
Froimson, AI. Tenosynovitis and Tennis Elbow; in Green's Operative Hand Surgery, 3rd Edition.
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. — View Citation
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. — View Citation
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. Epub 2007 May 4. — View Citation
Ryzewicz M, Wolf JM. Trigger digits: principles, management, and complications. J Hand Surg Am. 2006 Jan;31(1):135-46. Review. — View Citation
Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. Review. — View Citation
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. — View Citation
Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complications. 1997 Sep-Oct;11(5):287-90. — View Citation
Stefanich RJ, Peimer CA. Longitudinal incision for trigger finger release. J Hand Surg Am. 1989 Mar;14(2 Pt 1):316-7. — View Citation
Turowski GA, Zdankiewicz PD, Thomson JG. The results of surgical treatment of trigger finger. J Hand Surg Am. 1997 Jan;22(1):145-9. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale | 1 Year Follow-up | ||
| Secondary | Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score | 1 Year Follow-up |
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