Trial Outcomes & Findings for Endoscopic Trigger Finger Release (NCT NCT03883477)
NCT ID: NCT03883477
Last Updated: 2022-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
1 Week, 1 Month and 6 Months after surgery
Results posted on
2022-05-11
Participant Flow
Participant milestones
| Measure |
Endoscopic Release
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Endoscopic Release
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endoscopic Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=13 Participants
|
8 Participants
n=13 Participants
|
14 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
12 Participants
n=26 Participants
|
|
Age, Continuous
|
65.53 years
STANDARD_DEVIATION 14.25 • n=13 Participants
|
63.59 years
STANDARD_DEVIATION 10.66 • n=13 Participants
|
64.55 years
STANDARD_DEVIATION 12.36 • n=26 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
13 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=13 Participants
|
6 Participants
n=13 Participants
|
13 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 Week, 1 Month and 6 Months after surgeryPopulation: One patient in the Endoscopic Release group died from causes unrelated to the study and one patient in the Standard Open Release treatment arm did not complete the first post-operative survey. All subjects were included in the final statistical analysis.
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.
Outcome measures
| Measure |
Endoscopic Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)
1-Week Post-op
|
27.2 score on a scale
Standard Deviation 10.6
|
45.0 score on a scale
Standard Deviation 19.8
|
|
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)
1-Month Post-op
|
31.2 score on a scale
Standard Deviation 19.5
|
44.8 score on a scale
Standard Deviation 13.1
|
|
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)
6-Months Post-op
|
16.8 score on a scale
Standard Deviation 6.7
|
18.3 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: End of Study (6 months after treatment)Population: All available values included in the analysis.
The patient's overall satisfaction after surgery based on a 10 point scale with 1 indicating no satisfaction and 10 indicating extremely satisfied.
Outcome measures
| Measure |
Endoscopic Release
n=12 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=9 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Overall Patient Satisfaction: 10 Point Scale
|
9.2 score on a scale
Standard Deviation 2.6
|
8.2 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: End of study (6 months after treatment)Population: All available values included. Not applicable for retired patients.
Number of weeks after surgery before patient returns to work
Outcome measures
| Measure |
Endoscopic Release
n=9 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=8 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Weeks Before Return to Work
|
2.6 Weeks
Standard Deviation 3.0
|
4.4 Weeks
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: End of study (6 months after treatment)Population: All available data included in the analysis.
Number of days after surgery the patient participates in occupational therapy
Outcome measures
| Measure |
Endoscopic Release
n=12 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Duration of Post-operative Therapy
|
3.9 Days of therapy
Standard Deviation 3.7
|
5.7 Days of therapy
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: End of Study (6 months after treatment)Population: All available values included in analysis.
Number of days opiates used after surgery
Outcome measures
| Measure |
Endoscopic Release
n=12 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Pain Medication Use
|
0 Days
Standard Deviation 0
|
0.3 Days
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Through study completion, an average 1 yearInjury to tendons, nerves, or digital vessels, surgical site dehiscence or surgical site infections requiring antibiotics
Outcome measures
| Measure |
Endoscopic Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Number of Complications
|
0 Complications
|
1 Complications
|
SECONDARY outcome
Timeframe: At any time point after treatment; through study completion, an average 1 yearTriggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation
Outcome measures
| Measure |
Endoscopic Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.
Endoscopic Release: 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 Release
n=13 Participants
13 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.
Standard Open Release: Standard open surgical release of the A1 pulley for treatment of trigger finger.
|
|---|---|---|
|
Rate of Recurrence
|
0 Participants
|
1 Participants
|
Adverse Events
Endoscopic Release
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Open Release
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trial RN
Cedars-Sinai Medical Center, Department of Orthopedic Surgery
Phone: 3104235900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place