Endoscopic Trigger Finger Release
- Conditions
- Trigger Finger
- Interventions
- Device: Endoscopic ReleaseProcedure: Standard Open Release
- Registration Number
- NCT03883477
- Lead Sponsor
- Cedars-Sinai Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endoscopic Release Endoscopic Release 12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release. Standard Open Release Standard Open Release 12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
- Primary Outcome Measures
Name Time Method Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) 1 Week, 1 Month and 6 Months after surgery 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.
- Secondary Outcome Measures
Name Time Method Duration of Post-operative Therapy End of study (6 months after treatment) Number of days after surgery the patient participates in occupational therapy
Pain Medication Use End of Study (6 months after treatment) Number of days opiates used after surgery
Number of Complications Through study completion, an average 1 year Injury to tendons, nerves, or digital vessels, surgical site dehiscence or surgical site infections requiring antibiotics
Rate of Recurrence At any time point after treatment; through study completion, an average 1 year Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation
Overall Patient Satisfaction: 10 Point Scale End of Study (6 months after treatment) The patient's overall satisfaction after surgery based on a 10 point scale with 1 indicating no satisfaction and 10 indicating extremely satisfied.
Weeks Before Return to Work End of study (6 months after treatment) Number of weeks after surgery before patient returns to work
Trial Locations
- Locations (1)
Cedars-Sinai Department of Orthopedic Surgery
🇺🇸Los Angeles, California, United States