NCT05251428

Brief Summary

Trigger finger is a common condition of the hand caused by the thickening of the A1 pulley or flexor tendon that alters the way in which the flexor tendon glides within the tendon sheath. The purpose of this study is to evaluate the efficacy of excision versus incision of the A1 pulley for the trigger finger. Researchers hypothesize that excision of the A1 pulley would result in lower trigger finger recurrence rates, better pain relief, reduced soreness \& stiffness as well as higher final Patient-Reported Outcomes Measurement (PROMs). This will be investigated via a randomized controlled study involving patients randomized in either of the aforementioned surgical treatment groups, which are both standards of care, at the Musculoskeletal Institute or at the Emory University Orthopaedic and Spine Hospital. Patients will then follow up in the clinic at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year to assess their outcomes measures stated in the protocol document. All work related to this project will take place at the Emory Sports Medicine Complex, Emory Executive Park, Emory Musculoskeletal Institute, and the Emory University Orthopaedic and Spine Hospital. Patients will not be compensated for participating in this study. Patients who are undergoing trigger finger surgery will be identified by their Orthopaedic surgeon who is a member of the study team. The surgeon will briefly discuss participation with the patient and make clear study expectations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

February 1, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

February 1, 2022

Last Update Submit

January 20, 2026

Conditions

Trigger Finger

Outcome Measures

Primary Outcomes (1)

  • Change in the pain score

    Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain). A higher score indicates worse pain.

    Baseline and 6 weeks

Other Outcomes (4)

  • Change in the range of motion (ROM)

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

  • Change in patients' reported Working status

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

  • Change in the pain score

    Baseline, 2 weeks, 3 months, 6 months, and 1 year

  • +1 more other outcomes

Study Arms (2)

excision of the A1 pulley

EXPERIMENTAL
Procedure: Excision of the A1 pulley

incision of the A1 pulley in the standard fashion

ACTIVE COMPARATOR
Procedure: Incision of the A1 pulley in the standard fashion

Interventions

Incision of the A1 pulley in the standard fashionPROCEDURE

Participants will undergo incision of the A1 pulley in the standard fashion. Wounds will then be irrigated and closed in the standard fashion.

Also known as: Standard of care group
incision of the A1 pulley in the standard fashion
Excision of the A1 pulleyPROCEDURE

Participants will undergo excision of the A1 pulley. Wounds will then be irrigated and closed in the standard fashion.

Also known as: Intervention Group
excision of the A1 pulley

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • All patients undergoing surgery for trigger finger syndrome
  • Patients willing and able to provide informed consent

You may not qualify if:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Emory Orthopedic and Spine Hospital

Atlanta, Georgia, 30084, United States

Location

12 Executive Park Drive

Atlanta, Georgia, 30329, United States

Location

Emory Musculoskeletal Institute

Atlanta, Georgia, 30329, United States

Location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

Emory at Dunwoody

Atlanta, Georgia, 30338, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Eric Wagner, MD, MS

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 22, 2022

Study Start

January 30, 2023

Primary Completion

January 12, 2024

Study Completion

November 20, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)