Trigger FingerNCT02196233
Surgical Treatment of Adult Trigger Finger
An observational study of Trigger Finger, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Trigger Finger
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over the age of 18 presenting to the four attending surgeons with Trigger Finger
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Trigger Finger
- Keywords
- Trigger Finger, Prospective Clinical Research, Randomized, Questionnaires, Transverse, Longitudinal
- Medical subject headings
- Trigger Finger Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale
Measured: 1 Year Follow-up
Secondary outcomes (1)
Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score
Measured: 1 Year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startNov 2012
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Hutchinson, University of Utah
- Investigators
- Douglas Hutchinson, Principal investigator, Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196233
- Sponsor's protocol ID
- 60239
- Status last verified
- Aug 2019
- First submitted
- 17 Jul 2014
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11476534Ryzewicz 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.
PubMed 16443118Sato 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.
PubMed 22039269Stefanich 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.
PubMed 2703681Turowski 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.
PubMed 9018628Froimson, 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.
PubMed 3385301Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. No abstract available.
PubMed 20808746Brown 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.
PubMed 22123050Koh 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.
PubMed 19687073Griggs 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.
PubMed 8522745Lim 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.
PubMed 17482325Stahl 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.
PubMed 9334911van 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.
PubMed 16079683van 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.
PubMed 22249102
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Evaluating the Type of Incision on Outcomes and Patient Satisfaction in the Surgical Treatment of Trigger Finger
- ClinicalTrials.gov ID
- NCT02196233
- Acronym / sponsor ID
- 60239
- Conditions
- Trigger Finger
- Keywords
- Trigger Finger, Prospective Clinical Research, Randomized, Questionnaires, Transverse, Longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over the age of 18 presenting to the four attending surgeons with Trigger Finger
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale
Time frame: 1 Year Follow-up
1 secondary outcome
Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score
Time frame: 1 Year Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 11476534Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.
- Background: PubMed 16443118Ryzewicz 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.
- Background: PubMed 22039269Sato 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.
- Background: PubMed 2703681Stefanich 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.
- Background: PubMed 9018628Turowski 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.
- BackgroundFroimson, AI. Tenosynovitis and Tennis Elbow; in Green's Operative Hand Surgery, 3rd Edition.
- Background: PubMed 3385301Bonnici 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.
- Background: PubMed 20808746Bell MS. Trigger fingers: A checkmark incision. Can J Plast Surg. 2009 Fall;17(3):e18-9. No abstract available.
- Background: PubMed 22123050Brown 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.
- Background: PubMed 19687073Koh 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.
- Background: PubMed 8522745Griggs 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.
- Background: PubMed 17482325Lim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Hutchinson principal investigator
Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale (time frame: 1 Year Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196233, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.