Endoscopic Trigger Finger Release
Primary Purpose
Trigger Finger
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Release
Standard Open Release
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring Tendinopathy, Trigger Finger
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
Sites / Locations
- Cedars-Sinai Department of Orthopedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endoscopic Release
Standard Open Release
Arm Description
12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Weeks Before Return to Work
Number of weeks after surgery before patient returns to work
Duration of Post-operative Therapy
Number of days after surgery the patient participates in occupational therapy
Pain Medication Use
Number of days opiates used after surgery
Number of Complications
Injury to tendons, nerves, or digital vessels, surgical site dehiscence or surgical site infections requiring antibiotics
Rate of Recurrence
Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation
Full Information
NCT ID
NCT03883477
First Posted
March 15, 2019
Last Updated
April 16, 2022
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03883477
Brief Title
Endoscopic Trigger Finger Release
Official Title
Endoscopic Trigger Finger Release
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
September 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Tendinopathy, Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Release
Arm Type
Experimental
Arm Description
12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Arm Title
Standard Open Release
Arm Type
Active Comparator
Arm Description
12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Intervention Type
Device
Intervention Name(s)
Endoscopic Release
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Open Release
Intervention Description
Standard open surgical release of the A1 pulley for treatment of trigger finger.
Primary Outcome Measure Information:
Title
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)
Description
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
Secondary Outcome Measure Information:
Title
Overall Patient Satisfaction: 10 Point Scale
Description
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)
Title
Weeks Before Return to Work
Description
Number of weeks after surgery before patient returns to work
Time Frame
End of study (6 months after treatment)
Title
Duration of Post-operative Therapy
Description
Number of days after surgery the patient participates in occupational therapy
Time Frame
End of study (6 months after treatment)
Title
Pain Medication Use
Description
Number of days opiates used after surgery
Time Frame
End of Study (6 months after treatment)
Title
Number of Complications
Description
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
Title
Rate of Recurrence
Description
Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation
Time Frame
At any time point after treatment; through study completion, an average 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Kulber, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Department of Orthopedic Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
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Endoscopic Trigger Finger Release
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