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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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 surgical release of the A1 pulley for treatment of trigger finger.
Cedars-Sinai Department of Orthopedic Surgery
Los Angeles, California, United States
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.
Time frame: 1 Week, 1 Month and 6 Months after surgery
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.
Time frame: End of Study (6 months after treatment)
Weeks Before Return to Work
Number of weeks after surgery before patient returns to work
Time frame: End of study (6 months after treatment)
Duration of Post-operative Therapy
Number of days after surgery the patient participates in occupational therapy
Time frame: End of study (6 months after treatment)
Pain Medication Use
Number of days opiates used after surgery
Time frame: 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
Time frame: Through study completion, an average 1 year
Rate of Recurrence
Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation
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Time frame: At any time point after treatment; through study completion, an average 1 year