NCT03883477

Endoscopic Trigger Finger Release

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Trigger Finger

Interventions

Type	Name	Description
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.
PROCEDURE	Standard Open Release	Standard open surgical release of the A1 pulley for treatment of trigger finger.

Timeline

• Start date: 2019-03-13
• Primary completion: 2021-09-24
• Completion: 2021-09-24
• First posted: 2019-03-21
• Last updated: 2022-05-11
• Results posted: 2022-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study