Function and Scar in Trigger Finger Release
A Comparative Study of Hand Function and Scar-Related Health-Related Quality of Life in Trigger Finger Release
1 other identifier
observational
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2024
CompletedJune 24, 2024
June 1, 2024
5 years
July 13, 2022
June 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
1 week prior, 1 day prior, and 1, 3 and 12 months post operation
Study Arms (3)
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
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.
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.
Interventions
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.
Eligibility Criteria
Individuals receiving trigger finger release surgery from surgeons who are co-investigators in this study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Achilles Thoma, MD
McMaster University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgeon
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 28, 2022
Study Start
June 10, 2019
Primary Completion
June 18, 2024
Study Completion
June 18, 2024
Last Updated
June 24, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
we do not plan on sharing data with other researchers