Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05477290 |
| Other study ID # |
7242 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2019 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
March 2023 |
| Source |
McMaster University |
| Contact |
Achilles Thoma, MD |
| Phone |
(905) 523-0019 |
| Email |
athoma[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
