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Trigger FingerNCT05251428

Trigger Finger Trial

A study testing Excision of the A1 pulley and Incision of the A1 pulley in the standard fashion in people with Trigger Finger, run by Emory University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
Excision of the A1 pulley and Incision of the A1 pulley in the standard fashion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
6 sitesUnited States
Study dates
30 Jan 2023to 20 Nov 2025
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • Emory Orthopedic and Spine Hospital

    Atlanta, Georgia, 30084

  • 12 Executive Park Drive

    Atlanta, Georgia, 30329

  • Emory Musculoskeletal Institute

    Atlanta, Georgia, 30329

  • Emory Orthopaedics and Spine Center

    Atlanta, Georgia, 30329

  • Emory at Dunwoody

    Atlanta, Georgia, 30338

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: A Randomized Control Trial to Evaluate Incision Versus Excision of A1 Pulley for Trigger Finger

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.

Read the detailed description

Trigger finger is a common condition of the hand that affects up to 2.6% of the adult population over the course of their lifetimes. This prevalence is even higher in patients with diabetes affecting 5-20% of people. The condition is 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. While first-line therapy for this condition is conservative treatment through activity modification, bracing, and corticosteroid injections, this fails a reported 20-50% of the time. In cases in which conservative management failure occurs, surgery is the next line of treatment. The purpose of this study is to evaluate the efficacy of excision versus incision of the A1 pulley for the trigger finger. The research team hypothesizes 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 PROMs.

Surgery can be performed either percutaneously or open. Rates of persistent triggering in the percutaneous release group range from 7 to 9%. Additionally, even with open procedures, there is some risk of persistent triggering or symptom recurrence. A study by Everding et al. reported a recurrent triggering rate of 2.6% in their cohort of 795 patients who underwent open trigger finger release. A review of 209,634 patients who underwent trigger digit release from the PearlDiver Database reported a revision rate of 0.4% at 1 year and 0.64% at 3 years. Finally, a retrospective study by Bruijnzeel et al. demonstrated a 0.6% risk of persistent triggering and a 0.3% risk of recurrence in their sample of 1,598 patients. Risk factors for revision include Dupuytren's disease, rheumatoid arthritis, liver, disease, obesity, tobacco use, peripheral vascular disease, diabetes mellitus, and age under 65 years. In cases of recurrence, the procedure can be repeated to release any remaining portion of the A1 pulley, partial release of the A2, or release of the ulnar slip of flexor digitorum superficialis. Two biomechanical studies have demonstrated that the entire A1 pulley and up to 50% of the A2 pulley can be released with minimal risk for bowstringing.

There have also been studies assessing the use of different incision types for open procedures and their effects on scar formation. Kazmers et al. compared scar formation from trigger finger release through a transverse skin incision versus a longitudinal incision and found no difference in DASH scores, complication rates, or scar quality metrics in the 61 patients studied. Additionally, a study comparing a transverse incision at the distal palmar crease, a transverse incision 2-3 mm distal to the distal palmar crease, and a longitudinal incision at the level of the A1 pulley demonstrated similar results between the longitudinal incision and the incision 2-3 mm distal to the distal palmar crease with no difference in scar volume as measured by ultrasound. There have been no studies to date assessing the effect of complete A1 pulley resection in comparison to longitudinal release of the A1 pulley. Theoretically, resection of the A1 pulley should reduce the rate of persistent triggering and recurrence and thus result in superior patient outcomes; however, this has yet to be determined.

Conditions
Trigger Finger
Being tested
Excision of the A1 pulley, Incision of the A1 pulley in the standard fashion
Medical subject headings
Trigger Finger Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Excision of the A1 pulleyProcedure or surgery

    Also called Intervention Group

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

  • Incision of the A1 pulley in the standard fashionProcedure or surgery

    Also called Standard of care group

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

Study groups in NCT05251428
Study groupRoleWhat they receive
excision of the A1 pulleyExperimentalNot described
Receives: Procedure: Excision of the A1 pulley
incision of the A1 pulley in the standard fashionActive comparatorNot described
Receives: Procedure: Incision of the A1 pulley in the standard fashion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start30 Jan 2023
  3. Primary completion12 Jan 2024
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05251428
Sponsor's protocol ID
STUDY00003754
Status last verified
Jan 2026
First submitted
1 Feb 2022
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Excision of the A1 pulley and Incision of the A1 pulley in the standard fashion in people with Trigger Finger, run by Emory University at 6 sites in United States.

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 3 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 the pain score (time frame: Baseline and 6 weeks). 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 22 Jan 2026.

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