Endoscopic Trigger Finger Release

Trigger Finger Clinical Trial

Official title:

Endoscopic Trigger Finger Release

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883477
• Other study ID #: Pro00054088
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: September 24, 2021

Study information

• Verified date: April 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Department of Orthopedic Surgery	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Weeks Before Return to Work	Number of weeks after surgery before patient returns to work	End of study (6 months after treatment)
Secondary	Duration of Post-operative Therapy	Number of days after surgery the patient participates in occupational therapy	End of study (6 months after treatment)
Secondary	Pain Medication Use	Number of days opiates used after surgery	End of Study (6 months after treatment)
Secondary	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
Secondary	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