Endoscopic Trigger Finger Release

The purpose of this study is to compare recovery, scar, and patient satisfaction after retrograde endoscopic trigger finger release versus the standard open surgical treatment.

Study Overview

• Status: Completed
• Conditions: Trigger Finger
• Intervention / Treatment: Device: Endoscopic Release; Procedure: Standard Open Release

Detailed Description

Consecutive patients presenting with trigger finger interested in surgical release of the A1 pulley will be prospectively treated with endoscopic versus open surgical release of the A1 pulley. Study measures will include scar assessment based on the Patient and Observer Scar Assessment Scale (POSAS) administered at 1 week, 1 month, and 6 months post-operatively, overall satisfaction (scale of 1 to 10), days before return to work, duration of post-operative occupational therapy, pain medication use, operative time, and complication and recurrence rates.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Department of Orthopedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years old
• Trigger finger diagnosis, recommended for surgical release
• Be in good health other than the trigger finger
• Have realistic expectations of surgical results
• Be willing to undergo surgical or endoscopic treatment
• Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed

Exclusion Criteria:

• Collagen-vascular, connective tissue, or bleeding disorder
• Pregnancy
• Regional sympathetic dystrophy
• Abscess or infection at time of planned surgery
• Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic Release; 12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.	Device: Endoscopic Release; Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices.
Active Comparator: Standard Open Release; 12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.	Procedure: Standard Open Release; Standard open surgical release of the A1 pulley for treatment of trigger finger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)	Questionnaires, completed by both the patient and the patient's surgeon/Physician Assistant (PA-C), contain 6 items on a 10-point scale (1 is best, 10 is worst). Scores range from 12 to 120 with 12 indicating normal skin and 120 indicating worst scar imaginable.	1 Week, 1 Month and 6 Months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Patient Satisfaction: 10 Point Scale	The patient's overall satisfaction after surgery based on a 10 point scale with 1 indicating no satisfaction and 10 indicating extremely satisfied.	End of Study (6 months after treatment)
Weeks Before Return to Work	Number of weeks after surgery before patient returns to work	End of study (6 months after treatment)
Duration of Post-operative Therapy	Number of days after surgery the patient participates in occupational therapy	End of study (6 months after treatment)
Pain Medication Use	Number of days opiates used after surgery	End of Study (6 months after treatment)
Number of Complications	Injury to tendons, nerves, or digital vessels, surgical site dehiscence or surgical site infections requiring antibiotics	Through study completion, an average 1 year
Rate of Recurrence	Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation	At any time point after treatment; through study completion, an average 1 year

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: David A Kulber, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): September 24, 2021
• Study Completion (Actual): September 24, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Tendinopathy; Trigger Finger
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder
• Other Study ID Numbers: Pro00054088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes