NCT05477290

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

5 years

First QC Date

July 13, 2022

Last Update Submit

June 21, 2024

Conditions

Keywords

ScarFunctionHealth-Related Quality of Life

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

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.

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.

Procedure: Trigger Finger Release through Vertical Incision

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.

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.

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.

Vertical incision

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Trigger Finger DisorderCicatrix

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Achilles Thoma, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

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

Locations