Trigger FingerNCT05477290
Function and Scar in Trigger Finger Release
An observational study of Trigger Finger, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Trigger Finger Release through Transverse Incision, Trigger Finger Release through Oblique Incision and Trigger Finger Release through Vertical Incision
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2019to 18 Jun 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Individuals receiving trigger finger release surgery from surgeons who are co-investigators in this study.
Who may be able to join
- 18 years of age or older
- Trigger finger release of the 2nd, 3rd, 4th, or 5th finger
- Diagnosed stenosing tenosynovitis or trigger finger prior to release
- Able to understand and communicate English
Who cannot join
- Previous attempted surgical treatment
- Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release)
- Patients who are unable to provide informed consent.
- Patients who do not have a fixed address
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Hand Function and Scar-Related Health-Related Quality of Life in Trigger Finger Release
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.
Read the detailed 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.
- Conditions
- Trigger Finger
- Being tested
- Trigger Finger Release through Transverse Incision, Trigger Finger Release through Oblique Incision, Trigger Finger Release through Vertical Incision
- Keywords
- Scar, Function, Health-Related Quality of Life
- Medical subject headings
- Trigger Finger Disorder, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger Finger Release through Transverse IncisionProcedure or surgery
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.
Trigger Finger Release through Oblique IncisionProcedure or surgery
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.
Trigger Finger Release through Vertical IncisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transverse 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 Receives: Procedure: Trigger Finger Release through Transverse Incision | |
| Oblique 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. Receives: Procedure: Trigger Finger Release through Oblique Incision | |
| Vertical 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. Receives: Procedure: Trigger Finger Release through Vertical Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation
Secondary outcomes (1)
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.
Measured: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start10 Jun 2019
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achilleas Thoma, McMaster University
- Investigators
- Achilles Thoma, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477290
- Sponsor's protocol ID
- 7242
- Status last verified
- Jun 2024
- First submitted
- 13 Jul 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we do not plan on sharing data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Hand Function and Scar-Related Health-Related Quality of Life in Trigger Finger Release
- ClinicalTrials.gov ID
- NCT05477290
- Acronym / sponsor ID
- 7242
- Conditions
- Trigger Finger
- Keywords
- Scar, Function, Health-Related Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 28 Jul 2022 (actual)
- 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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transverse incision | – | Procedure: Trigger Finger Release through Transverse IncisionAt 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 |
| Oblique incision | – | Procedure: Trigger Finger Release through Oblique IncisionAt 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. |
| Vertical incision | – | Procedure: Trigger Finger Release through Vertical IncisionAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals receiving trigger finger release surgery from surgeons who are co-investigators in this study.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Trigger finger release of the 2nd, 3rd, 4th, or 5th finger
- Diagnosed stenosing tenosynovitis or trigger finger prior to release
- Able to understand and communicate English
Key exclusion criteria (4 listed)
- Previous attempted surgical treatment
- Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release)
- Patients who are unable to provide informed consent.
- Patients who do not have a fixed address
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigger Finger Release through Transverse IncisionAt 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 or surgery | Transverse incision |
| Trigger Finger Release through Oblique IncisionAt 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 or surgery | Oblique incision |
| Trigger Finger Release through Vertical IncisionAt 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 or surgery | Vertical incision |
Primary outcome
Change in Health-Related Quality of Life related to hand function
Time frame: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation
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.
1 secondary outcome
Change in Health-Related Quality of Life related to scar appearance
Time frame: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation
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 24 Jun 2024.
- Individual participant dataSharing planned: No. we do not plan on sharing data with other researchers
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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.
Achilles Thoma, MD principal investigator
McMaster University
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 McMaster University at 1 site in Canada.
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 4 inclusion and 4 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 24 Jun 2024. 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 Canada. 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?
Change in Health-Related Quality of Life related to hand function (time frame: 1 week prior, 1 day prior, and 1, 3 and 12 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.