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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Release | Experimental | 12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release. |
|
| Standard Open Release | Active Comparator | 12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Release | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Kulber, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Department of Orthopedic Surgery | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 Week, 1 Month and 6 Months after surgery |
|
Through study completion, an average 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Lack of randomization and blinding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial RN | Cedars-Sinai Medical Center, Department of Orthopedic Surgery | 3104235900 | rodriquezsv@csmns.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2020 | Jan 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
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| Standard Open Release | Procedure | Standard open surgical release of the A1 pulley for treatment of trigger finger. |
|
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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | 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. |
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| 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. | All available values included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | End of Study (6 months after treatment) |
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| Secondary | Weeks Before Return to Work | Number of weeks after surgery before patient returns to work | All available values included. Not applicable for retired patients. | Posted | Mean | Standard Deviation | Weeks | End of study (6 months after treatment) |
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| Secondary | Duration of Post-operative Therapy | Number of days after surgery the patient participates in occupational therapy | All available data included in the analysis. | Posted | Mean | Standard Deviation | Days of therapy | End of study (6 months after treatment) |
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| Secondary | Pain Medication Use | Number of days opiates used after surgery | All available values included in analysis. | Posted | Mean | Standard Deviation | Days | End of Study (6 months after treatment) |
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| Secondary | Number of Complications | Injury to tendons, nerves, or digital vessels, surgical site dehiscence or surgical site infections requiring antibiotics | Posted | Number | Complications | Through study completion, an average 1 year |
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| Secondary | Rate of Recurrence | Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation | Posted | Count of Participants | Participants | At any time point after treatment; through study completion, an average 1 year |
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| 1 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D014947 |
| Wounds and Injuries |