An observational study in Trigger Finger, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by McMaster University · Observational
Trigger finger is a common upper limb impairment associated with a significant decrease in quality of life, hand dexterity and strength as well as increased pain while complying daily activities of living. Trigger finger can be managed through the surgical release of the ligaments in the affected finger. The open surgical release of trigger finger can be accomplished through multiple incision types. As such, each incision may present different risks of harming or disturbing the underlying anatomy in the hand. This study aims to assess the variation in three incisional techniques (oblique, transverse and vertical) to determine which incision is preferential to improve scar aesthetics, increase hand function and minimize complications. Patients will be observed following surgery and information about hand function and quality of life will be obtained through the administration of questionnaires. Data will be collected at four time-points, one prior to and three following surgery.
A study describing the superior incision technique is still needed to assess post-open release outcomes of the surgical site such as aesthetics and hand function. This study contributes to literature by providing further clarification into which technique of open trigger finger release is preferential to optimize scar aesthetics, increase function and, minimize complications using patient reported outcome measures such as the MHQ and SCAR-Q. The primary objective of this study is to assess patient Health-Related Quality of Life related to hand function via three incisional techniques using the generic hand instrument, (MHQ). This will be measured at 1 week prior, 1 day prior, and 1, 3, and 6 months post operation. The secondary objective will be to evaluate the Health-Related Quality of Life related to scar appearance post trigger finger release of three (transverse, oblique and vertical) incisional techniques of trigger finger release using the SCAR-Q (a condition-specific scales) at 1, 3 and 6 months post operation.
This study will be employed as a three-arm prospective cohort study. Local surgeons practicing at St. Joseph's Healthcare who utilize different incisional techniques for trigger finger release will compare each of their techniques. As each group sees trigger finger at a roughly equal rate, it is expected that the target of 30 patients in each group will be met in a similar timeline. Data will be recorded by a research team member that is not the operating physician via a paper-based system specific to this study.
At consultation patients will be approached for consent within a private consultation room within the surgical clinic. One week prior to surgery patients will complete questionnaires at the principle investigator's office (completed by the RA) in a private room. Post operation, patients will return to the principle investigator's office at 1, 3, 6 and 12 months post operation to complete the same questionnaires and to document any complications they have experienced.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's enrollment of 75 is above the median of 68 across 14 observational studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Individuals receiving trigger finger release surgery from surgeons who are co-investigators in this study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At the level of the A1 pulley, a transverse incision will be made and the flexor pulley will be exposed with blunt dissection. The pulley will be transected and the wound will subsequently be closed with 4.0 Monocryl after ensuring complete release
Procedure: Trigger Finger Release through Transverse Incision
At the level of the A1 pulley, a oblique incision will be made and the flexor pulley will be exposed with blunt dissection. The pulley will be transected and the wound will subsequently be closed with 4.0 Monocryl after ensuring complete release.
Procedure: Trigger Finger Release through Oblique Incision
At the level of the A1 pulley, a vertical incision will be made and the flexor pulley will be exposed with blunt dissection. The pulley will be transected and the wound will subsequently be closed with 4.0 Monocryl after ensuring complete release.
Procedure: Trigger Finger Release through Vertical Incision
At the level of the A1 pulley, a transverse incision will be made and the flexor pulley will be exposed with blunt dissection. The pulley will be transected and the wound will subsequently be closed with 4.0 Monocryl after ensuring complete release.
At the level of the A1 pulley, a oblique incision will be made and the flexor pulley will be exposed with blunt dissection. The pulley will be transected and the wound will subsequently be closed with 4.0 Monocryl after ensuring complete release.
At the level of the A1 pulley, a vertical incision will be made and the flexor pulley will be exposed with blunt dissection. The pulley will be transected and the wound will subsequently be closed with 4.0 Monocryl after ensuring complete release.
Change in Health-Related Quality of Life related to hand function
Outcome measured through the Michigan Hand Questionnaire (MHQ). The MHQ has a total score of 100; the lowest possible score is 0. A score of 100 on the MHQ indicates the best possible ability.
Time frame: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation
Change in Health-Related Quality of Life related to scar appearance
Scar appearance, symptoms and the psychosocial impact of the scar will be measured using the SCAR-Q. This questionnaire has a minimum score of 0 and a maximum score of 100 with higher scores indicating a better outcome.
Time frame: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation
Plan to share: No — we do not plan on sharing data with other researchers
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Jun 2024, 60 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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