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Trigger Finger Trial

Primary Purpose

Trigger Finger

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Excision of the A1 pulley
Incision of the A1 pulley in the standard fashion
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Orthopedic and Spine HospitalRecruiting
  • 12 Executive Park DriveRecruiting
  • Emory Musculoskeletal InstituteRecruiting
  • Emory Orthopaedics and Spine CenterRecruiting
  • Emory at DunwoodyRecruiting
  • Emory Saint Joseph's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

excision of the A1 pulley

incision of the A1 pulley in the standard fashion

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2022
Last Updated
February 28, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05251428
Brief Title
Trigger Finger Trial
Official Title
A Randomized Control Trial to Evaluate Incision Versus Excision of A1 Pulley for Trigger Finger
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
excision of the A1 pulley
Arm Type
Experimental
Arm Title
incision of the A1 pulley in the standard fashion
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Excision of the A1 pulley
Other Intervention Name(s)
Intervention Group
Intervention Description
Participants will undergo excision of the A1 pulley. Wounds will then be irrigated and closed in the standard fashion.
Intervention Type
Procedure
Intervention Name(s)
Incision of the A1 pulley in the standard fashion
Other Intervention Name(s)
Standard of care group
Intervention Description
Participants will undergo incision of the A1 pulley in the standard fashion. Wounds will then be irrigated and closed in the standard fashion.
Primary Outcome Measure Information:
Title
Change in the pain score
Description
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
Other Pre-specified Outcome Measures:
Title
Change in the range of motion (ROM)
Description
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
Title
Change in patients' reported Working status
Description
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
Title
Change in the pain score
Description
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
Title
Recurrent trigger finger after A1 pulley release
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD, MS
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Orthopedic and Spine Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric R Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Facility Name
12 Executive Park Drive
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Facility Name
Emory Musculoskeletal Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Gonzalez, MD
Phone
404-778-5834
Email
felix.m.gonzalez@emory.edu
Facility Name
Emory at Dunwoody
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Trigger Finger Trial

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