Endoscopic Trigger Finger Release
Phase: NA
Conditions: Trigger Finger
Sponsor: Cedars-Sinai Medical Center

ENDOSCOPIC TRIGGER FINGER RELEASE 
Protocol Number: 00054088 
National Clinical Trial (NCT) Identified Number: NCT03883477 
Principal Investigator: Dr. David Kulber 
Sponsor: Cedars-Sinai Medical Center 
Version Number:  v5 
01 December 2020

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
2 
Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................................................................................. 4 
1 
PROTOCOL SUMMARY ......................................................................................................................................................................... 4 
1.1 
Synopsis ............................................................................................................................................................................................ 4 
1.2 
Schema ............................................................................................................................................................................................... 7 
2 
INTRODUCTION ...................................................................................................................................................................................... 8 
2.1 
Abbreviations and Terms: ......................................................................................................................................................... 8 
2.2 
Background and Clinical Rationale for Data Review ..................................................................................................... 8 
3 
STUDY OBJECTIVES .............................................................................................................................................................................. 8 
4 
STUDY DESIGN ........................................................................................................................................................................................ 8 
4.1 
Overall Design ................................................................................................................................................................................. 8 
4.2 
Study Structure .............................................................................................................................................................................. 9 
4.3 
Duration ............................................................................................................................................................................................ 9 
4.4 
Study Questionnaires/Assessment ....................................................................................................................................... 9 
4.5 
Visits & Procedures ...................................................................................................................................................................... 9 
5 
STUDY POPULATION CHARACTERISTICS .................................................................................................................................. 9 
5.1 
Number of Subjects ................................................................................................................................................................... 10 
5.2 
Study Population Characteristics ........................................................................................................................................ 10 
5.3 
Inclusion Criteria ........................................................................................................................................................................ 10 
5.4 
Exclusion Criteria Procedures .............................................................................................................................................. 10 
6 
Visits & Procedures ............................................................................................................................................................................ 11 
6.1 
Pre-screening & Visits .............................................................................................................................................................. 11 
6.1.1 
Procedures for Final Study Entry ............................................................................................................................ 11 
6.1.2 
Pre-operative Visits 11 
6.1.3 
Follow-up Visits 
11 
6.2 
Standard and Research Procedures ................................................................................................................................... 11 
6.3 
Surgical Procedures .................................................................................................................................................................. 12 
6.4 
Medical Imaging .......................................................................................................................................................................... 12 
6.5 
Instructions for the Subjects ................................................................................................................................................. 12 
6.6 
Unscheduled Visits .................................................................................................................................................................... 12 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................................................. 13 
7.1 
Early Discontinuation of Subjects ....................................................................................................................................... 13 
8 
OUTCOME MEASURES AND SUMMARY OF METHODS OF DATA COLLECTION ..................................................... 13 
8.1 
Outcome Measures .................................................................................................................................................................... 13 
8.1.1 
Primary Outcome Measure ........................................................................................................................................ 13 
8.1.2 
Secondary Outcome Measures ................................................................................................................................. 14 
8.1.3 
Exploratory Measures .................................................................................................................................................. 14 
8.2 
Safety Measures .......................................................................................................................................................................... 14 
8.3 
Summary of Methods of Data Collection .......................................................................................................................... 14 
9 
STATISTICAL PROCEDURES .......................................................................................................................................................... 14 
9.1 
Populations for Analyses ........................................................................................................................................................ 15 
9.2 
Collection and Derivation of Primary and Secondary Outcome Measures ....................................................... 15 
9.2.1 
Primary Outcome Measures ...................................................................................................................................... 15 
9.2.2 
Secondary Outcome Measures ................................................................................................................................. 15 
9.2.3 
Exploratory Measures .................................................................................................................................................. 15 
9.3 
Hypothesis and Methods of Analysis ................................................................................................................................. 16 
9.3.1 
Primary Outcome Measure Analysis ...................................................................................................................... 16 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
3 
9.3.2 
Secondary Outcome Measure Analysis ................................................................................................................. 16 
9.3.3 
Exploratory Measures Analysis ................................................................................................................................ 16 
9.3.4 
Safety Analysis 
16 
9.4 
Subgroup Analysis ..................................................................................................................................................................... 16 
9.5 
Exploratory Analyses ............................................................................................................................................................... 17 
9.6 
Sample Size Calculation ........................................................................................................................................................... 17 
9.7 
Interim Analyses ......................................................................................................................................................................... 17 
9.8 
Protocol Deviations ................................................................................................................................................................... 17 
10 
STUDY ADMINISTRATION PROCEDURES ............................................................................................................................. 18 
10.1 
Subject Entry Procedures ................................................................................................................................................. 18 
10.1.1 
Overview of Entry Procedures ................................................................................................................................. 18 
10.1.2 
Informed Consent and Subject Privacy ................................................................................................................. 18 
10.2 
Compliance with Protocol ................................................................................................................................................ 18 
10.3 
Study Termination ............................................................................................................................................................... 19 
11 
ADVERSE EVENTS ............................................................................................................................................................................ 19 
11.1 
Definitions ............................................................................................................................................................................... 19 
11.1.1 
Adverse Event 
20 
11.1.2 
Serious Adverse Event ................................................................................................................................................. 20 
11.2 
Procedures for Reporting Adverse Events ................................................................................................................ 21 
11.3 
Reporting an SAE .................................................................................................................................................................. 21 
12 
ADMINISTRATIVE ISSUES ............................................................................................................................................................ 21 
12.1 
Protection of Human Subjects ........................................................................................................................................ 21 
12.1.1 
Compliance with Informed Consent Regulations ............................................................................................. 21 
12.1.2 
Compliance with IRB Regulations ........................................................................................................................... 21 
12.1.3 
Compliance with Good Clinical Practice ............................................................................................................... 21 
12.2 
Subject Confidentiality and Privacy ............................................................................................................................. 22 
12.3 
Documentation ...................................................................................................................................................................... 22 
12.3.1 
Source Documents 22 
12.3.2 
Document Completion ................................................................................................................................................. 23 
12.3.3 
Retention of Documentation ..................................................................................................................................... 23 
13 
REFERENCES ...................................................................................................................................................................................... 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
4 
STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Conference on Harmonisation 
Good Clinical Practice (ICH GCP) and the applicable United States (US) Code of Federal 
Regulations (CFR). The Principal Investigator will assure that no deviation from, or changes 
to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this 
study have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval.  Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled.  Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented 
to the study.  All changes to the consent form will be IRB approved; a determination will be 
made regarding whether a new consent needs to be obtained from participants who 
provided consent, using a previously approved consent form. 
 
1 
PROTOCOL SUMMARY 
 
1.1 
SYNOPSIS 
 
Title of the Study: Endoscopic Trigger Finger Release 
 
Number of Subjects: 24 
 
Objective: The objective of this study is to compare recovery, scar and patient 
satisfaction after retrograde endoscopic trigger finger release versus standard open 
surgical treatment. 
 
Methodology: 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.. 
 
Visit Schedule: Pre-operative visit, post-operative visits at 1 week, 1 month, and 6 
months post-operatively. 
 
Diagnosis and Main Inclusion Criteria for Inclusion/Exclusion:  Subjects with 
diagnosis of trigger finger. 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
5 
 
Inclusion Criteria: 
• Male or Female >18 years of age 
• Trigger finger, recommended for surgical release 
• Be in good health other than the trigger finger 
• Have realistic expectations of surgical results 
• Understand and be willing to follow all aspects of the study protocol and 
have signed and dated the IRB-approved 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: To be eligible for enrollment, the subject must not: 
• Have collagen-vascular, connective tissue, or bleeding disorders  
• Be a smoker or have smoked in last 2 months  
• Have any disease, including uncontrolled diabetes, which is clinically known 
to impact wound healing ability  
• Have regional sympathetic dystrophy  
• Be pregnant, lactating or expecting to be within the next 24 months  
• Currently have an alcohol/substance abuse problem or have had a relapse 
within one year to screening visit 
• Have an abscess or infection at the time of 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 
 
Duration of the Study: Subjects will be followed for 6 months post release of the A1 
pulley. 
 
Criteria for Evaluation: Primary outcome measures include scarring based on 
Patient and Observer Scar Assessment Scale (POSAS) scores administered 1 week, 1 
month, and 6 months post-operatively between patients treated with endoscopic 
versus open surgical release of the A1 pulley. Secondary outcome measures include 
overall satisfaction (scale of 1 to 10), days to return to work, duration of post-
operative occupational therapy, pain medication use as well as complication and 
recurrence rates between the two treatment groups.  
 
Statistical Methods: 
 
Sample size calculation:  Total POSAS scores range from 12 to 120. Though the 
POSAS has not been used to assess scarring after trigger finger release, the tool is 
validated with high internal consistency and reliability.1 
 
A total of 24 patients (12 in the endoscopic arm and 12 in the standard open arm) 
will provide sufficient information to produce descriptive summaries of study 
outcome endpoints and to perform exploratory analyses. 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
6 
 
The purpose of this study is to compare scar and recovery after retrograde 
endoscopic trigger finger release versus standard open surgical treatment. We 
hypothesize that patients treated with the retrograde endoscopic approach will 
have improved scarring compared to patients treated with the open approach, 
based on POSAS scores. We also hypothesize that the patients in the endoscopic 
treatment arm will have a faster recovery (return to work sooner with fewer days of 
occupational therapy), have higher overall satisfaction (scale 1 to 10) and use less 
pain medication. We anticipate that the two treatments will not differ significantly 
in complication or recurrence rate.  
 
Schedule of Visits and Procedures: As depicted in Section 1.2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
7 
1.2 
SCHEMA 
       
 
 
 
 
 
 
         
 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
8 
2 
INTRODUCTION 
 
2.1 
ABBREVIATIONS AND TERMS:  
 
OT Occupational therapy 
POSAS Patient and Observer Scar Assessment Scale 
 
2.2 
BACKGROUND AND CLINICAL RATIONALE FOR DATA REVIEW 
 
Trigger finger is an entrapment tendinopathy in which the flexor tendon catches 
within a thickened or narrowed A1 pulley with flexion and extension of the digit.2,3 
Patients present with complaints of pain, snapping, or locking of the finger at the 
MCP joint4.  With an incidence between 2 and 3%  in the general population, trigger 
finger is one of the most common causes of  disability and pain in the hand.3,5,6 
 
Initial treatment is conservative and nonsurgical management includes: non-
steroidal anti-inflammatory drugs, activity modification, splinting, and 
corticosteroid injections.7,8 Though some relief may be noted initially, the reported 
recurrence rate after corticosteroid treatment is up to 48%.9 Definitive treatment 
often requires release of the A1 pulley through an open, percutaneous, or 
endoscopic surgical technique. In the open approach, an incision is made in the palm 
- most commonly at the distal palmar crease - which causes great discomfort to 
patients.10,11  The endoscopic approach reported by Pegoli and colleagues requires 
two incisions: one at the proximal interphalangeal crease and one in the mid palm.11 
The percutaneous approach avoids use of these painful palmar incisions, but 
concerns exist over the safety of this blind technique.12 As such, techniques 
currently available for the surgical treatment of trigger finger fall short in one of two 
ways: 1) they require an incision of the palm, which can be painful and unsightly to 
patients or 2) the release is performed blindly. 
 
3 
STUDY OBJECTIVES 
 
 The objective of this study is to compare scar and recovery after retrograde 
endoscopic trigger finger release versus standard open surgical treatment. 
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
9 
Consecutive patients (until 12 patients are enrolled in each treatment arm) 
presenting with trigger finger interested in surgical release of the A1 pulley will be 
offered participation in the study. Additional subjects may be enrolled, as needed to 
achieve 12 patients in each treatment arm, in the event of patient death or 
withdrawal from the study. Once enrolled, they will be treated with one of two 
techniques: endoscopic versus open surgical release. 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.  
 
4.2 
STUDY STRUCTURE 
 
This is a prospective clinical trial, as the participants will be treated, after 
enrollment, with endoscopic versus open release.  
 
4.3 
DURATION 
 
Subjects will be followed for 6 months post-operatively. POSAS scores will be 
obtained at 1 week, 1 month, and 6 months post-operatively. These scores along 
with measures of pain medication use, days before return to work, and duration of 
OT will be obtained from each subject during their post-operative visit. 
Complication and recurrence rates will also be noted at each post-operative visit. 
Study visits will coincide with standard clinical course visits. 
  
4.4 
STUDY QUESTIONNAIRES/ASSESSMENT 
 
The patients of Dr. David Kulber, Dr. Eugene Tsai, Dr. Ryan DellaMaggiora, and Dr. 
Stuart Kuschner eligible to participate in the study will proceed with baseline 
assessments once study consents have been signed and the patient has been 
enrolled in the study. 
 
4.5 
VISITS & PROCEDURES 
 
Patients will undergo endoscopic or open treatment. Follow-up assessments will be 
performed at 1 week, 1 month, and 6 months post-operatively.  
 
5 
STUDY POPULATION CHARACTERISTICS 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
10 
5.1 
NUMBER OF SUBJECTS 
 
Consecutive patients presenting with trigger finger interested in surgical release of 
the A1 pulley will undergo endoscopic versus open surgical release of the A1 pulley. 
A total of 12 subjects are to be enrolled for each treatment arm. Additional subjects 
may be enrolled, as needed to achieve 12 patients in each treatment arm, in the 
event of patient death or withdrawal from the study. 
5.2 
STUDY POPULATION CHARACTERISTICS 
 
Subjects who meet the inclusion/exclusion criteria detailed below will be enrolled 
into the study. 
 
5.3 
INCLUSION CRITERIA 
 
 
• Male or Female >18 years of age 
• Trigger finger, recommended for surgical release 
• Be in good health other than the trigger finger 
• Have realistic expectations of surgical results 
• Be willing to undergo treatment based on the treatment arm to which they 
are randomized 
• Understand and be willing to follow all aspects of the study protocol and 
have signed and dated the IRB-approved 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 
 
5.4 
EXCLUSION CRITERIA PROCEDURES 
 
• Have collagen-vascular, connective tissue, or bleeding disorders  
• Be a smoker or have smoked in last 2 months  
• Have any disease, including uncontrolled diabetes, which is clinically known 
to impact wound healing ability  
• Have regional sympathetic dystrophy  
• Be pregnant, lactating or expecting to be within the next 24 months  
• Currently have an alcohol/substance abuse problem or have had a relapse 
within one year to screening visit 
• Have an abscess or infection at the time of 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 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
11 
 
6 
VISITS & PROCEDURES 
 
6.1 
PRE-SCREENING & VISITS 
 
The physician’s appointment calendar will be pre-screened of potential study 
candidates who would be eligible for surgical treatment. No study related data will 
be collected/administered until patient has signed consent and HIPAA. 
 
6.1.1 PROCEDURES FOR FINAL STUDY ENTRY 
 
A subject is considered “enrolled” when he/she has signed the IRB-approved 
consent form and HIPAA authorization in the presence of the Investigator, who will 
then collect and record the subject’s demographic information and medical history. 
 
6.1.2 PRE-OPERATIVE VISITS 
 
The subject will be screened in accordance with the inclusion/exclusion criteria, 
medical history will be collected, a physical exam will be performed and medical 
photography will be obtained, as is the standard of care. 
 
6.1.3 FOLLOW-UP VISITS 
 
Subjects will be required to attend post-operative visits at 1 week, 1 month, and 6 
months post-operatively, as is the standard of care. Review of medical history and 
physical examination will be conducted at all post-operative visits. At 1 week, 1 
month, and 6 months post-operatively, pain medication use, days before return to 
work, duration of occupational therapy, as well as POSAS scores will be obtained 
and photos will be taken.  
 
6.2 
STANDARD AND RESEARCH PROCEDURES 
 
All evaluations, procedures performed, and information obtained during pre-
operative and post-operative visits will be within the standard of care with the 
exception of the POSAS questionnaire. The POSAS questionnaire contains a Patient 
Scale to be completed by the patient and an Observer Scale to be completed by the 
patient’s surgeon-of-record. The Patient Scale is comprised of 6 questions regarding 
pain, itching, color, stiffness, thickness, and irregularity of their scar scored 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
12 
numerically from 1 to 10.  There is a 7th question, also on a scale of 1 to 10, that asks 
the patient for their overall opinion of the scar.  
 
The POSAS questionnaire will be completed by patients at 1 week, 1 month, and 6 
months post-operatively. In an effort to minimize inconvenience and avoid undue 
stress to the subjects, they will be given unlimited time to complete the 
questionnaire and will be allowed to skip questions as desired. 
6.3 
SURGICAL PROCEDURES 
 
For subjects in open surgical treatment arm: A transverse incision is made at the 
distal palmar crease overlying the affected digit. Blunt dissection proceeds down to 
the level of the A1 pulley and the pulley is incised under direct visualization. The 
surgical site will then be irrigated and closed in usual fashion. 
 
For subjects endoscopic treatment arm: The proximal interphalangeal crease is 
identified of the affected finger and incised transversely. Blunt dissection is then 
performed down to the level of the pulley. With the finger held in extension, the 
EndoSleeve is inserted from distal to proximal at a 15 degree angle. The A1 pulley is 
visualized via the endoscope. The tip of the EndoSleeve is then situated on the distal 
edge of the A1 pulley. As the tip is advanced proximally, the blade is seen incising 
the A1 pulley. The instrument is advanced to a point just before the distal palmar 
crease. The surrounding tissue is then inspected and the instrument removed. The 
surgical site is then irrigated and closed in usual fashion.  
 
6.4 
MEDICAL IMAGING 
  
Photographs of the affected hand will be taken per medical photographic standards 
pre-operatively, on the day of surgery, and 1 week, 1 month, and 6 months post-op 
as is the standard of care.  
 
A copy of any medical imaging results (e.g., hand radiology) collected during the 
study duration will be included in the study file. No radiographic imaging is required 
for the study.  
 
6.5 
INSTRUCTIONS FOR THE SUBJECTS 
 
There are no special instructions for the subjects beyond those typically provided 
for hand surgery and in the informed consent. Subjects will be asked to complete the 
POSAS questionnaire at 1 week, 1 month, and 6 months post-operatively. 
 
6.6 
UNSCHEDULED VISITS 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
13 
 
Each time the subject returns to the study site the Investigator will solicit and 
record information about any concurrent procedures or AEs as applicable though 
not anticipated. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
EARLY DISCONTINUATION OF SUBJECTS 
 
Each subject reserves the right to withdraw from the study at any time without 
jeopardy to their future medical care. All follow-up assessments and procedures 
should be performed at the final study visit. For any subject who discontinues from 
the study, the date and reason for discontinuation will be recorded. 
 
If a subject fails to return for one or more scheduled study visits, the Investigator 
will attempt to contact the subject to determine and document the reason the 
subject has failed to return and to encourage compliance with the study visit 
schedule. 
 
A subject may be discontinued from the study for the following reasons: 
• Subject did not undergo surgical treatment as it was deemed not warranted 
by the Investigator 
• Since enrollment in the study, subject has had alternative treatment that 
would otherwise affect the study questionnaire/outcomes data 
• Subject does not complete scheduled follow-up visits per protocol 
• Subject has died 
 
8 
OUTCOME MEASURES AND SUMMARY OF METHODS OF DATA 
COLLECTION 
 
8.1 
OUTCOME MEASURES 
8.1.1 PRIMARY OUTCOME MEASURE 
 
Primary outcome measures include scarring based on Patient and Observer Scar 
Assessment Scale (POSAS) scores administered 1 week, 1 month, and 6 months 
post-operatively between patients treated with endoscopic versus open surgical 
release of the A1 pulley.  
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
14 
8.1.2 SECONDARY OUTCOME MEASURES 
 
Secondary outcome measures include pain medication use, overall patient 
satisfaction (score 1 to 10), days to return to work, and duration of post-operative 
occupational therapy as well as complication and recurrence rates after endoscopic 
versus open surgical treatment. Complications will include injury to tendons, 
nerves, and digital vessels noted during or after surgical treatment, as well as 
surgical site dehiscence and surgical site infections requiring antibiotics. Recurrence 
will be defined as triggering, confirmed on physical exam by treating physician, at 
any time point post-operatively. 
 
 
8.1.3 EXPLORATORY MEASURES 
 
• Operative time 
 
8.2 
SAFETY MEASURES 
 
The incidence and severity of AEs related to the study will be captured. 
Investigators will inquire about the occurrence of any AEs at all study visits and 
unscheduled visits. Subjects will also be asked to self- report AEs throughout the 
duration of the study. Adverse events will be recorded. 
 
8.3 
SUMMARY OF METHODS OF DATA COLLECTION 
 
Paper documents will be used to collect standardized assessments for POSAS scores. 
Study-specific information, such as Investigator reviews and assessments will be 
recorded directly in the subject’s medical record. 
 
Pain medication use, days before return to work, duration of OT, complications, and 
recurrences will be recorded by the Investigator in the subjects’ medical record. 
 
Operative time will be obtained from the operative record within the patient’s 
electronic medical chart, as recorded by operative staff.  
9 
STATISTICAL PROCEDURES 
 
Every attempt will be made to collect complete data and limit the occurrence of 
missing data. Due to the descriptive nature of all analyses, no imputation of missing 
data will be performed. Descriptive summaries will be based on all observations 
available within each of the relevant analysis populations.  

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
15 
 
Descriptive statistics will be presented for key outcome measures. 
 
9.1 
POPULATIONS FOR ANALYSES 
 
All subjects will be included in the full analysis population. The per protocol 
population is defined as subjects who have not had any major protocol deviations 
throughout the study (Section 9.8) and will be analyzed as the primary study group. 
Other subgroups may be analyzed as detailed in the subgroup analyses section. 
Subjects that have been discontinued will be excluded from data analysis. 
 
9.2 
COLLECTION AND DERIVATION OF PRIMARY AND SECONDARY OUTCOME 
MEASURES 
 
All exploratory variables will be analyzed as reported, without further derivation, 
except for the calculation of change from baseline, or change from prior time-points. 
 
9.2.1 PRIMARY OUTCOME MEASURES 
 
 Primary outcome measures include scarring based on Patient and Observer Scar 
Assessment Scale (POSAS) scores administered 1 week, 1 month, and 6 months 
post-operatively between patients treated with endoscopic versus open surgical 
release of the A1 pulley. 
9.2.2 SECONDARY OUTCOME MEASURES 
 
 
Secondary outcome measures include pain medication use, overall patient 
satisfaction (score 1 to 10), days to return to work, and duration of post-operative 
occupational therapy as well as complication and recurrence rates after endoscopic 
versus open surgical treatment. Complications will include injury to tendons, 
nerves, and digital vessels noted during or after surgical treatment, as well as 
surgical site dehiscence and surgical site infections requiring antibiotics. Recurrence 
will be defined as triggering, confirmed on physical exam by treating physician, at 
any time point post-operatively.  
 
9.2.3 EXPLORATORY MEASURES 
Operative time will be obtained from the operative record within the patient’s 
electronic medical chart, as recorded by operative staff.  
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
16 
9.3 
HYPOTHESIS AND METHODS OF ANALYSIS 
 
We hypothesize that patients treated with the retrograde endoscopic approach will 
have improved scarring compared to patients treated with the open approach, 
based on POSAS scores obtained at 1 week, 1 month, and 6 months post-operatively. 
We also hypothesize that the patients in the endoscopic treatment arm will have a 
faster recovery (return to work sooner with fewer days of occupational therapy), 
have higher overall satisfaction (scale 1 to 10) and use less pain medication. We 
anticipate that the two treatments will not differ significantly in complication or 
recurrence rate. 
9.3.1 PRIMARY OUTCOME MEASURE ANALYSIS 
 
 Primary outcome measures of POSAS scores at 1 week, 1 month, and 6months post-
operatively will be analyzed using descriptive statistics, including n, mean, standard 
deviation, median, minimum, maximum, and skewness. 
 
9.3.2 SECONDARY OUTCOME MEASURE ANALYSIS 
 
Secondary outcome measures of pain medication use, overall satisfaction (scale 1 to 
10), days to return to work, days of occupational therapy, complication rate, and 
recurrence rate will be analyzed using descriptive statistics, including n, mean, 
standard deviation, median, minimum, maximum, and skewness.  
 
9.3.3 EXPLORATORY MEASURES ANALYSIS 
 
All exploratory variables will be summarized with descriptive statistics appropriate 
to the scale of measurement for each variable. 
 
9.3.4 SAFETY ANALYSIS 
 
Safety analyses will include the incidence and severity of adverse events observed 
over the study assessment period. These will be tabulated and presented overall 
and by relatedness, severity, and preferred term. 
 
9.4 
SUBGROUP ANALYSIS 
 
Subgroup analyses will be performed to explore their relationship to key study 
outcomes. 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
17 
9.5 
EXPLORATORY ANALYSES 
 
POSAS scores at 1 week, 1 month, and 6 months post-operatively will be analyzed 
between patients treated with endoscopic versus open release using 2-sample t-
tests. Differences in pain medication use, days before return to work, duration of OT, 
operative time, overall satisfaction, complication and recurrence rates between 
patients treated with endoscopic versus open surgical release of the A1 pulley will 
be tested for significance using 2-sample t-tests.  Additional analyses of possible 
relationships between outcomes may also be performed using appropriate 
inferential tests. 
 
9.6 
SAMPLE SIZE CALCULATION 
 
Total POSAS scores range from 12 to 120. Though the POSAS has not been used to 
assess scarring after trigger finger release, the tool is validated with high internal 
consistency and reliability.1 
 
The trial will be powered to detect a difference in POSAS score of 10, deemed to be 
clinically significant by the investigators. The POSAS standard deviations in studies 
previously published on carpal tunnel release and carotid endarterectomies ranges 
from 1.0 to 11.0.13,14 To detect a mean difference in POSAS score of 10 points (SD = 
8) with a two-sided significance level of 5% and power of 80% with equal allocation 
to two arms would require 12 patients in each arm of the trial. Additional subjects 
may be enrolled, as needed to achieve 12 patients in each treatment arm, in the 
event of patient death or withdrawal from the study. 
 
9.7 
INTERIM ANALYSES 
 
Not applicable. 
 
9.8 
PROTOCOL DEVIATIONS 
 
Protocol deviations may include: 
• Deviations from the protocol, contrary to protocol specifications (i.e., 
deviations from the protocol, eligibility, visit windows, etc.). 
• Deviations affecting the endpoint outcome not previously specified in the 
protocol (i.e., deviation that had not been previously considered in the 
protocol or eligibility criteria, however having a clear impact on the primary 
outcome measure)  

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
18 
All protocol deviations will be reviewed and categorized as major (i.e., those that 
affect measurement or interpretation of the primary endpoint) or minor (those not 
affecting the primary endpoint). 
 
10 STUDY ADMINISTRATION PROCEDURES 
 
10.1 SUBJECT ENTRY PROCEDURES 
 
10.1.1 OVERVIEW OF ENTRY PROCEDURES 
 
Prospective subjects as defined by the criteria in Section 5.3 and 5.4 
(inclusion/exclusion criteria) will be considered for entry into this study. 
 
10.1.2 INFORMED CONSENT AND SUBJECT PRIVACY 
 
The purpose, procedures, risks, benefits, and alternatives to study participation will 
be discussed with each potential subject. Prior to any study-related procedures or 
change in treatment, subjects wishing to participate must give their written 
informed consent (IC). The subject must also give Authorization for Use and Release 
of Health and Research Study Information (HIPAA) and other written 
documentation in accordance with the relevant country and local privacy 
requirements (where applicable) prior to any study-related 
assessments/questionnaires. Subjects will be consented to provide a copy of all 
medical imaging (e.g. radiology) collected as standard-of-care or research during the 
study duration for inclusion in the study file. The Investigator will conduct the IC 
discussion and will document in the subject’s medical records the process for 
acquiring IC and the subject’s agreement or refusal to notify her primary care 
physician about the study. The subject should personally sign and date the IC form. 
The Investigator will retain the original copy of the signed IC form, and the subject 
will also receive a copy. Upon signing the IC form, the subject will receive a subject 
number that will be used on all documentation for the subject throughout the study. 
Subject numbers should be assigned in ascending order, and numbers should not be 
omitted or reused. The subject number is a unique identification for each subject. 
 
10.2 COMPLIANCE WITH PROTOCOL 
 
All eligible subjects to be treated by Dr. David Kulber, Dr. Eugene Tsai, Dr. Ryan 
DellaMaggiora, and Dr. Stuart Kuschner will be counseled on the techniques 
available for surgical release of the A1 pulley. Enrolled patients in both treatment 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
19 
arms will be asked to complete POSAS questionnaires as indicated within the 
schedule outlined in section 6. 
 
The Investigator is responsible for the overall conduct of the study and compliance 
with the protocol including subject recruitment, IC, screening evaluations, eligibility, 
assessment/procedure, study evaluations, and any study-related medical care. The 
Investigator may choose to delegate some of these tasks to suitably trained research 
staff personnel, but the Investigator is ultimately responsible for these activities. 
 
10.3 STUDY TERMINATION 
 
If conditions arise during the study that indicate that the study should be 
terminated, the Investigator, Monitor, IRB, and/or regulatory agencies will discuss 
the situation and take appropriate action after consultation. Conditions that may 
warrant termination of the study or site include, but are not limited to: 
• Discovery of an unexpected, serious, or unacceptable risk to subjects enrolled 
in the study 
• Failure of the Investigator to comply with pertinent national or state 
regulations, IRB imposed conditions, or protocol requirements 
• Submission of knowingly false information from the Investigator to IRB, or 
any regulatory agency 
 
11 ADVERSE EVENTS 
 
Throughout the course of the study, AEs will be monitored and reported on an AE 
CRF, including seriousness, severity, relationship to device, and action taken. If AEs 
occur, the first concern will be the safety of the study participants. The Investigator 
and the research staff will monitor each subject closely, and record any 
complications that may arise, though not anticipated. Study clinicians will use 
his/her medical judgment to do whatever is necessary to help treat the problem. 
Potential risks and/or side effects include:  
 
Foreseeable Risk  
• Discomfort  
• Pain  
• Redness  
• Swelling  
• Scarring 
• Local or systemic infection  
• Dehiscence and/or necrosis due to poor revascularization  
 
11.1 DEFINITIONS 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
20 
 
11.1.1 ADVERSE EVENT 
 
An adverse event (AE) is any untoward medical occurrence in a subject that does 
not necessarily have a causal relationship with the treatment. An adverse event can 
therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or temporal disease, whether or not related to the 
study assessment(s)/questionnaire(s). 
 
Pre-existing disease or symptoms thereof prior to study enrollment are not 
considered AEs unless the condition recurs after the subject has recovered from the 
pre-existing condition, or the condition worsens in intensity or frequency during the 
study. Normal post-operative sequelae will not be recorded as adverse events. 
Specifically, normal post-operative pain, swelling, tenderness, loss of skin sensation 
and ecchymosis within the first two weeks postoperative, requiring normal levels of 
medication will not be recorded; all abnormal intensity or duration will be recorded 
and considered an adverse event as well as following the two-week post-operative 
period. 
 
Adverse events will be monitored throughout the study. At each post-baseline visit, 
the Investigator will begin querying for adverse events by asking each subject a 
general, nondirected question such as “Have you had any changes to your condition 
since your last visit?” Previous adverse events and changes in therapy/concomitant 
medications should be updated. Directed questioning and examination will then be 
done as appropriate. All reported adverse events will be documented. 
 
 
11.1.2 SERIOUS ADVERSE EVENT 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that 
at any dose:  
• results in death 
• is life-threatening  
• requires inpatient hospitalization or prolongation of existing hospitalization 
• results in persistent or significant disability/incapacity 
• is a congenital anomaly/birth defect  
 
Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, they may jeopardize the subject or subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
21 
11.2 PROCEDURES FOR REPORTING ADVERSE EVENTS 
 
Adverse events should be reported to governing IRB per governing IRB reporting 
requirements. 
 
11.3 REPORTING AN SAE 
 
Any SAE occurring during the study period and for at least 30 days after the last 
study visit should be immediately reported (within 24 hours) and recorded. The 
Investigator should supply the Sponsor and the IRB with any additional requested 
information (e.g., hospital discharge summary, autopsy report, pathology report, 
operative report, terminal medical report, etc.). 
 
12 ADMINISTRATIVE ISSUES 
 
This protocol is to be conducted in accordance with the applicable Good Clinical 
Practice regulations and guidelines, e.g., the International Conference on 
Harmonisation (ICH) Guideline on Good Clinical Practice (GCP). 
 
12.1 PROTECTION OF HUMAN SUBJECTS 
 
12.1.1 COMPLIANCE WITH INFORMED CONSENT REGULATIONS 
 
Written informed consent is to be obtained from each subject prior to enrollment 
into the study, and/or from the subject’s legally authorized representative. The 
process for obtaining informed consent must also be documented in the subject’s 
medical record. 
 
12.1.2 COMPLIANCE WITH IRB REGULATIONS 
 
This study is to be conducted in accordance with applicable IRB regulations. The 
Investigator must obtain approval from a properly constituted IRB prior to initiating 
the study and re-approval or review at least annually. 
 
12.1.3 COMPLIANCE WITH GOOD CLINICAL PRACTICE 
 
This protocol is to be conducted in accordance with the applicable GCP regulations 
and guidelines. 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
22 
 
12.2 SUBJECT CONFIDENTIALITY AND PRIVACY 
 
A report of the results of this study may be published, but the subject’s name will 
not be disclosed in these documents. The subject’s name may be disclosed to the 
study Sponsor, the governing health authorities or the Food and Drug 
Administration (FDA), if they inspect the study records. Appropriate precautions 
will be taken to maintain confidentiality of medical records and personal 
information.  
 
Written Authorization and other documentation in accordance with the relevant 
country and local privacy requirements (where applicable) are to be obtained from 
each subject prior to enrollment into the study, and/or from the subject’s legally 
authorized representative in accordance with the applicable privacy requirements 
(e.g., HIPAA). 
 
12.3 DOCUMENTATION 
 
12.3.1 SOURCE DOCUMENTS 
 
Source documents may include a subject’s original (or certified copy) medical 
records, hospital charts, clinic charts, the Investigator’s subject study files, as well as 
the results of diagnostic tests. 
 
The following information should be entered into the subject’s medical record: 
• Subject’s name 
• Subject’s contact information 
• Date that the subject entered the study and subject number 
• The study title and/or the protocol number 
• A statement that informed consent was obtained and the process for 
obtaining consent, including the date. A statement that HIPAA Authorization 
or other country and local subject privacy required documentation for this 
study has been obtained, including the date.  
• Dates of all subject visits 
• All concomitant procedures 
• Subject standardized radiology as specified in the outcome metrics 
• Occurrence, treatment for, and status of any adverse events 
• Date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for discontinuation. 
• Protocol deviations, as applicable 
 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
23 
12.3.2 DOCUMENT COMPLETION 
 
Source documents must meet the criteria to be acceptable in assessing the quality 
and integrity of the data during inspection or review of that data: attributable, 
legible, contemporaneous, original, accurate and available upon request. The 
Investigator is responsible for ensuring that data is properly recorded on each 
subject’s record. 
 
12.3.3 RETENTION OF DOCUMENTATION 
 
All study related correspondence, subject records, consent forms, subject privacy 
documentation, records of the distribution and use of device, and copies of 
documentation should be maintained on file. Documents should be retained and 
available for audit by regulatory authorities until at least 2 years after the latest 
among the following scenarios: completion or termination of the study, the 
last approval of a marketing application, no pending or contemplated marketing 
applications, or formal discontinuation of clinical development of the device. These 
documents should be retained for a longer period, however, if mandated by the 
applicable regulatory requirements, by conditions imposed by the IRB. 
 
13 REFERENCES 
 
1. Van de Kar, AL, Corion, LU, Smeulders, MJ, Draaijers, LJ, van der Horst, CM, 
van Zuijlen, PP. Reliable and feasible evaluation of linear scars by the Patient 
and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005;116:514-522. 
2. Sampson SP, Badalamente MA, Hurst LC, Seidman J. Pathobiology 
of the human A1 pulley in trigger finger. J Hand Surg Am. 
1991;16(4):714e721. 
3. Wolfe SW. Tendinopathy. In: Wolfe SW. Green’s Operative Hand Surgery. 7th 
ed. Philadelphia, PA: Elsevier/Churchill Livingstone; 2005;56:1904-1925. 
4. Ryzewicz M, Wolf JM. Trigger digits: principles, management, and 
complications. Journal of Hand Surgery. 2006;31(1):135-46. 
5. Strom L. Trigger finger in diabetes. Journal of the Medical Society of New 
Jersey. 1977;74(11):951-4. 
6. Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, 
evaluation, and treatment. Curr Rev Musculoskelet Med. 2008;1(2):92e96. 
7. Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or 
operate. Journal of Hand Surgery. 1992;17(1):110-3. 
8. Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger 
finger. Journal of Hand Surgery. 1995;20(4):628-31. 
9. Rhoades CE, Gelberman RH, Manjarris JF. Stenosing tenosynovitis of the 
fingers and thumb. Results of a prospective trial of steroid injection and 
splinting. Clinical Orthopaedics and Related Research. 1984;190:236-8. 

Endoscopic Trigger Finger Release  
Protocol Number 00054088 
 
Version 5 
  
24 
10. Kloeters O, Ulrich DJO, Bloemsma G, van Houdt CIA. Comparison of three 
different incision techniques in A1 pulleyrelease on scar tissue formation and 
postoperative rehabilitation. Archives of Orthopaedic and Trauma 
Surgery. 2016;136(5):731-7. 
11. Pegoli L, Cavalli E, Cortese P, Parolo C, Pajardi G. A comparison of endoscopic 
and open trigger finger release. Hand Surgery. 2008;13(3):147-51. 
12. Fiorini HJ, Tamaoki MJ, Lenza M, Gomes Dos Santos J, Faloppa F, Belloti J. 
Surgery for trigger finger. The Cochrane Database of Systematic Reviews. 
2018. 
13. Theopold C, Potter S, Dempsey M, O’Shaughnessy M. A randomised controlled 
trial of absorbable versus non-absorbable sutures for skin closure after open 
carpal tunnel release. Journal of Hand Surgery (European Volume). 
2012;37(4):350-3. 
14. Kazimierczak A, Rybicka A, Rynio P, Gutowski P, Wiernicki I. Cosmetic effects 
of skin-crease camouflage incision versus longitudinal incision following 
carotid endarterectomy. Videosurgery and Other Miniinvasive Techniques. 
2018 Mar;13(1):102.