- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196233
Surgical Treatment of Adult Trigger Finger
A Prospective, Randomized Trial Evaluating the Type of Incision on Outcomes and Patient Satisfaction in the Surgical Treatment of Trigger Finger
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale
Time Frame: 1 Year Follow-up
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1 Year Follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score
Time Frame: 1 Year Follow-up
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1 Year Follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Douglas Hutchinson, Orthopedic Surgery
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Froimson, AI. Tenosynovitis and Tennis Elbow; in Green's Operative Hand Surgery, 3rd Edition.
- 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.
- Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. No abstract available.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60239
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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