Trigger Finger
Conditions
Keywords
Tendinopathy, Trigger Finger
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.
Interventions
DEVICEEndoscopic 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.
PROCEDUREStandard Open Release
Standard open surgical release of the A1 pulley for treatment of trigger finger.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Weeks Before Return to Work | End of study (6 months after treatment) | Number of weeks after surgery before patient returns to work |
| Duration of Post-operative Therapy | End of study (6 months after treatment) | Number of days after surgery the patient participates in occupational therapy |
| 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. |
| 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 |
| Pain Medication Use | End of Study (6 months after treatment) | Number of days opiates used after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Open Release | Endoscopic Release | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Continuous | 63.59 years STANDARD_DEVIATION 10.66 | 65.53 years STANDARD_DEVIATION 14.25 | 64.55 years STANDARD_DEVIATION 12.36 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
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.
Time frame: 1 Week, 1 Month and 6 Months after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Endoscopic Release | 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 |
| Endoscopic Release | 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 |
| Endoscopic Release | 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 |
| Standard Open Release | Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) | 1-Week Post-op | 45.0 score on a scale | Standard Deviation 19.8 |
| Standard Open Release | Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) | 1-Month Post-op | 44.8 score on a scale | Standard Deviation 13.1 |
| Standard Open Release | Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) | 6-Months Post-op | 18.3 score on a scale | Standard Deviation 8.1 |
p-value: 0.013Wilcoxon (Mann-Whitney)
Comparison: The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. 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 required 12 patients in each arm of the trial.p-value: 0.007Wilcoxon (Mann-Whitney)
Comparison: The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. 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 required 12 patients in each arm of the trial.p-value: 0.804Wilcoxon (Mann-Whitney)
Secondary
Duration of Post-operative Therapy
Number of days after surgery the patient participates in occupational therapy
Time frame: End of study (6 months after treatment)
Population: All available data included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endoscopic Release | Duration of Post-operative Therapy | 3.9 Days of therapy | Standard Deviation 3.7 |
| Standard Open Release | Duration of Post-operative Therapy | 5.7 Days of therapy | Standard Deviation 5.7 |
p-value: 0.748Wilcoxon (Mann-Whitney)
Secondary
Number of Complications
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endoscopic Release | Number of Complications | 0 Complications |
| Standard Open Release | Number of Complications | 1 Complications |
p-value: 0.382Chi-squared
Secondary
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.
Time frame: End of Study (6 months after treatment)
Population: All available values included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endoscopic Release | Overall Patient Satisfaction: 10 Point Scale | 9.2 score on a scale | Standard Deviation 2.6 |
| Standard Open Release | Overall Patient Satisfaction: 10 Point Scale | 8.2 score on a scale | Standard Deviation 3 |
p-value: 0.142Wilcoxon (Mann-Whitney)
Secondary
Pain Medication Use
Number of days opiates used after surgery
Time frame: End of Study (6 months after treatment)
Population: All available values included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endoscopic Release | Pain Medication Use | 0 Days | Standard Deviation 0 |
| Standard Open Release | Pain Medication Use | 0.3 Days | Standard Deviation 0.8 |
p-value: 0.184Wilcoxon (Mann-Whitney)
Secondary
Rate of Recurrence
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Release | Rate of Recurrence | 0 Participants |
| Standard Open Release | Rate of Recurrence | 1 Participants |
p-value: 0.382Chi-squared
Secondary
Weeks Before Return to Work
Number of weeks after surgery before patient returns to work
Time frame: End of study (6 months after treatment)
Population: All available values included. Not applicable for retired patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endoscopic Release | Weeks Before Return to Work | 2.6 Weeks | Standard Deviation 3 |
| Standard Open Release | Weeks Before Return to Work | 4.4 Weeks | Standard Deviation 5.7 |
p-value: 0.561Wilcoxon (Mann-Whitney)