Trigger FingerNCT03883477
Endoscopic Trigger Finger Release
A study testing Endoscopic Release and Standard Open Release in people with Trigger Finger, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Endoscopic Release and Standard Open Release
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 24 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Department of Orthopedic Surgery
Los Angeles, California, 90048
About this study
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.
Read the 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.
- Conditions
- Trigger Finger
- Being tested
- Endoscopic Release, Standard Open Release
- Keywords
- Tendinopathy, Trigger Finger
- Medical subject headings
- Trigger Finger Disorder, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ReleaseDevice
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 ReleaseProcedure or surgery
Standard open surgical release of the A1 pulley for treatment of trigger finger.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Release | Experimental | 12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release. Receives: Device: Endoscopic Release |
| Standard Open Release | Active comparator | 12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release. Receives: Procedure: Standard Open Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Week, 1 Month and 6 Months after surgery
Secondary outcomes (6)
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.
Measured: End of Study (6 months after treatment)
Weeks Before Return to Work
Number of weeks after surgery before patient returns to work
Measured: End of study (6 months after treatment)
Duration of Post-operative Therapy
Number of days after surgery the patient participates in occupational therapy
Measured: End of study (6 months after treatment)
Pain Medication Use
Number of days opiates used after surgery
Measured: 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
Measured: Through study completion, an average 1 year
Rate of Recurrence
Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation
Measured: At any time point after treatment; through study completion, an average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start13 Mar 2019
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kulber, MD, Cedars-Sinai Medical Center
- Investigators
- David A Kulber, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883477
- Sponsor's protocol ID
- Pro00054088
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2019
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Trigger Finger Release
- ClinicalTrials.gov ID
- NCT03883477
- Acronym / sponsor ID
- Pro00054088
- Conditions
- Trigger Finger
- Keywords
- Tendinopathy, Trigger Finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 11 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Release | Experimental | Device: Endoscopic Release12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release. |
| Standard Open Release | Active comparator | Procedure: Standard Open Release12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ReleaseRetrograde 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. | Device | Endoscopic Release |
| Standard Open ReleaseStandard open surgical release of the A1 pulley for treatment of trigger finger. | Procedure or surgery | Standard Open Release |
Primary outcome
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 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.
6 secondary outcomes
Overall Patient Satisfaction: 10 Point Scale
Time frame: End of Study (6 months after treatment)
Weeks Before Return to Work
Time frame: End of study (6 months after treatment)
Duration of Post-operative Therapy
Time frame: End of study (6 months after treatment)
Pain Medication Use
Time frame: End of Study (6 months after treatment)
Number of Complications
Time frame: Through study completion, an average 1 year
Rate of Recurrence
Time frame: At any time point after treatment; through study completion, an average 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Kulber, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Release and Standard Open Release in people with Trigger Finger, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) (time frame: 1 Week, 1 Month and 6 Months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.