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.
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
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 group | Role | What they receive |
|---|---|---|
| excision of the A1 pulley | Experimental | Not described Receives: Procedure: Excision of the A1 pulley |
| incision of the A1 pulley in the standard fashion | Active comparator | Not 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.
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.
- First posted22 Feb 2022
- Study start30 Jan 2023
- Primary completion12 Jan 2024
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Wagner, Emory University
- Investigators
- Eric Wagner, MD, MS, Principal investigator, Emory University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Evaluate Incision Versus Excision of A1 Pulley for Trigger Finger
- ClinicalTrials.gov ID
- NCT05251428
- Acronym / sponsor ID
- STUDY00003754
- Conditions
- Trigger Finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- All patients undergoing surgery for trigger finger syndrome
- Patients willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision of the A1 pulleyAlso: Intervention GroupParticipants will undergo excision of the A1 pulley. Wounds will then be irrigated and closed in the standard fashion. | Procedure or surgery | excision of the A1 pulley |
| Incision of the A1 pulley in the standard fashionAlso: Standard of care groupParticipants will undergo incision of the A1 pulley in the standard fashion. Wounds will then be irrigated and closed in the standard fashion. | Procedure or surgery | incision of the A1 pulley in the standard fashion |
Primary outcome
Change in the pain score
Time frame: Baseline and 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Wagner, MD, MS principal investigator
Emory University
6 sites in 1 country: see every site and its status.
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.