Endoscopic Trigger Finger Release

NCT ID: NCT03883477

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2021-09-24

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Release

12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.

Group Type: EXPERIMENTAL

Endoscopic Release

Intervention Type: DEVICE

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.

Standard Open Release

12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.

Group Type: ACTIVE_COMPARATOR

Standard Open Release

Intervention Type: PROCEDURE

Standard open surgical release of the A1 pulley for treatment of trigger finger.

Interventions

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.

Intervention Type: DEVICE

Standard Open Release

Standard open surgical release of the A1 pulley for treatment of trigger finger.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Kulber, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Kulber, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Department of Orthopedic Surgery

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00054088

Identifier Type: -

Identifier Source: org_study_id