Endoscopic Trigger Finger Release

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Trigger Finger Release

Conditions
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Trigger Finger

Intervention / Treatment
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* Device: Endoscopic Release
* Procedure: Standard Open Release


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Release<br>12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release. | Device: Endoscopic Release<br>* 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.<br>|
| Active Comparator: Standard Open Release<br>12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release. | Procedure: Standard Open Release<br>* Standard open surgical release of the A1 pulley for treatment of trigger finger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Weeks Before Return to Work | Number of weeks after surgery before patient returns to work | End of study (6 months after treatment) | 
| Duration of Post-operative Therapy | Number of days after surgery the patient participates in occupational therapy | End of study (6 months after treatment) | 
| Pain Medication Use | Number of days opiates used after surgery | 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 | Through study completion, an average 1 year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tendinopathy, Trigger Finger