Clinical trial NCT03883477: Endoscopic Trigger Finger Release
Official title: Endoscopic Trigger Finger Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Finger
Keywords: Tendinopathy
Trigger Finger
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 1 Week, 1 Month and 6 Months after surgery
Secondary outcomes:
measure: Overall Patient Satisfaction: 10 Point Scale
timeFrame: End of Study (6 months after treatment)
measure: Weeks Before Return to Work
timeFrame: End of study (6 months after treatment)
measure: Duration of Post-operative Therapy
timeFrame: End of study (6 months after treatment)
measure: Pain Medication Use
timeFrame: End of Study (6 months after treatment)
measure: Number of Complications
timeFrame: Through study completion, an average 1 year
measure: Rate of Recurrence
timeFrame: At any time point after treatment; through study completion, an average 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Department of Orthopedic Surgery
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: David A Kulber, MD
role: PRINCIPAL_INVESTIGATOR
References: