An interventional study of Excision of the A1 pulley and Incision of the A1 pulley in the standard fashion in Trigger Finger, sponsored by Emory University. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's enrollment of 80 is above the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Excision of the A1 pulley
Procedure: Incision of the A1 pulley in the standard fashion
Participants will undergo excision of the A1 pulley. Wounds will then be irrigated and closed in the standard fashion.
Also known as: Intervention Group
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
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.
Time frame: Baseline and 6 weeks
Change in the range of motion (ROM)
Participants will be asked to complete questionnaires to evaluate their stiffness at each follow-up visit. The range of motion (ROM) will be measured using a finger goniometer ranging from 0 to 180 degrees. Additional hand function outcomes will be measured using the Disabilities of Arm, Shoulder, and Hand Questionnaire (DASH) which consists of subjectively rating the difficulty of a list of activities of daily living from 0-5 (0: no difficulty, 5=unable).
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Change in patients' reported Working status
The Upper Extremity Patient-Reported Outcomes Program (PROM) is a patient outcomes questionnaire that will be completed by the study participant at every visit. This questionnaire is administered electronically on a Microsoft tablet in the study room with the study participants' own password-secured profile log. The questionnaire consists of the subjective scores described above (DASH, VAS) as well as questions pertaining to current work status (unable to work, employed, caregiver/homemaker, retired).
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
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.
Time frame: Baseline, 2 weeks, 3 months, 6 months, and 1 year
Recurrent trigger finger after A1 pulley release
The research team will assess participants for recurrence of their symptoms. Recurrence of the trigger finger is defined as finger triggering after the surgery. Finger triggering is described as the involved finger becoming stuck in a bent position and straightening with a snap, like a trigger being pulled and released. This is a clinical manifestation of the pathology, evaluated and determined by the treating surgeon.
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Plan to share: No
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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