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Function and Scar in Trigger Finger Release

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ClinicalTrials.gov Identifier: NCT05477290
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : March 31, 2023
Sponsor:
Information provided by (Responsible Party):
Achilleas Thoma, McMaster University

Study Description
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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.

Condition or disease Intervention/treatment
Trigger Finger Procedure: Trigger Finger Release through Transverse Incision Procedure: Trigger Finger Release through Oblique Incision Procedure: Trigger Finger Release through Vertical Incision

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
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparative Study of Hand Function and Scar-Related Health-Related Quality of Life in Trigger Finger Release
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Procedure: Trigger Finger Release through 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.
 Procedure: Trigger Finger Release through 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.
 Procedure: Trigger Finger Release through 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals receiving trigger finger release surgery from surgeons who are co-investigators in this study.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Previous attempted surgical treatment
  2. Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release)
  3. Patients who are unable to provide informed consent.
  4. Patients who do not have a fixed address
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05477290


Contacts
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Contact: Achilles Thoma, MD (905) 523-0019 athoma@mcmaster.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Achilles Thoma, MD    905-523-0019    drathoma@cogeco.net   
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Achilles Thoma, MD McMaster University
More Information
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Responsible Party: Achilleas Thoma, Surgeon, McMaster University
ClinicalTrials.gov Identifier: NCT05477290    
Other Study ID Numbers: 7242
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we do not plan on sharing data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Achilleas Thoma, McMaster University:
Scar
Function
Health-Related Quality of Life
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases