Trigger Finger Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Trigger Finger
• Intervention / Treatment: Procedure: Excision of the A1 pulley; Procedure: Incision of the A1 pulley in the standard fashion

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Wagner, MD, MS; Phone Number: 404-778-7249; Email: eric.r.wagner@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Emory Saint Joseph's Hospital
      • Contact: Eric Wagner, MD, MS; Phone Number: 404-778-7249; Email: eric.r.wagner@emory.edu
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory Orthopaedics and Spine Center
      • Contact: Felix Gonzalez, MD; Phone Number: 404-778-5834; Email: felix.m.gonzalez@emory.edu
    • Atlanta, Georgia, United States, 30084
      • Recruiting
      • Emory Orthopedic and Spine Hospital
      • Contact: Eric R Wagner, MD, MS; Phone Number: 404-778-7249; Email: eric.r.wagner@emory.edu
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • 12 Executive Park Drive
      • Contact: Eric Wagner, MD, MS; Phone Number: 404-778-7249; Email: eric.r.wagner@emory.edu
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory Musculoskeletal Institute
      • Contact: Eric Wagner, MD, MS; Phone Number: 404-778-7249; Email: eric.r.wagner@emory.edu
    • Atlanta, Georgia, United States, 30338
      • Recruiting
      • Emory at Dunwoody
      • Contact: Eric Wagner, MD, MS; Phone Number: 404-778-7249; Email: eric.r.wagner@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: excision of the A1 pulley	Procedure: Excision of the A1 pulley; Participants will undergo excision of the A1 pulley. Wounds will then be irrigated and closed in the standard fashion.; Other Names: Intervention Group
Active Comparator: incision of the A1 pulley in the standard fashion	Procedure: Incision of the A1 pulley in the standard fashion; Participants will undergo incision of the A1 pulley in the standard fashion. Wounds will then be irrigated and closed in the standard fashion.; Other Names: Standard of care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patients' reported satisfaction	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 satisfaction with the surgery (unsatisfied to extremely satisfied).	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).	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Change in patients' reported demand of daily activities	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 questions pertaining to describing the physical demand of daily activities (Sedentary; not strenuous to Very strenuous; lifting >100lbs).	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Changes in the number of participants using pain medication	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 questions pertaining to the use of pain medication for pain control (yes/no).	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Change in patients' reported quantity of pain medication pills per day	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 the quantity of pain medication pills per day (none to >30), need for pain medication refills (1 to >3)	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Change in patients' reported side effects from pain medications	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 questions listing side effects from pain medication if any (select from a list of side effects).	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Change in patients' reported pain interference subjective score in the day-to-day activities	The Upper Extremity Patient-Reported Outcomes Measurement Information System (PROMIS) 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 PROMIS pain interference subjective score (series of questions pertaining to different aspects of daily living: e.g. How much did the pain interfere with your day-to-day activities? Rated from "Not at all" to "Very much".	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Change in patients' reported pain interference subjective score in social activities	The Upper Extremity Patient-Reported Outcomes Measurement Information System (PROMIS) 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 will have a question: How much did the pain interferes with your ability to participate in social activities? etc.) rated from "Not at all" to "Very much".	Baseline, 2 weeks, 6 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.	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 2 weeks, 6 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.	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
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).	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.	Baseline, 2 weeks, 3 months, 6 months, and 1 year

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Eric Wagner, MD, MS, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder
• Other Study ID Numbers: STUDY00003754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No