Surgical Release of Ai Pulley Trigger FingerPhase 2/3NCT02830672
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger
A Phase 2/3 study testing Surgical release A1 pulley for Trigger finger of the hand in people with Surgical Release of Ai Pulley Trigger Finger, run by National and Kapodistrian University of Athens.
Trial summary
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Release of Ai Pulley Trigger Finger
- What is being tested?
- Surgical release A1 pulley for Trigger finger of the hand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.
Who cannot join
- Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
- Patients with multiple trigger fingers
About this study
Official title: Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.
- Being tested
- Surgical release A1 pulley for Trigger finger of the hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical release A1 pulley for Trigger finger of the handProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Open surgical release A1 Pulley | Active comparator | Not described Receives: Procedure: Surgical release A1 pulley for Trigger finger of the hand |
| Ultrasound guided close release A1 pulley | Active comparator | Not described Receives: Procedure: Surgical release A1 pulley for Trigger finger of the hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of triggering expressed as the "success rate" per digit.
Measured: 12 weeks
Secondary outcomes (5)
The time for taking postoperative pain killers
Measured: 12 weeks
Range of motion recovery
Measured: 12 weeks
QuickDASH test scores (Greek version)
Measured: 12 weeks
Time to return to normal activities (including work)
Measured: 12 weeks
Cosmetic results
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start1 Nov 2015
- Primary completion1 Oct 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Release of Ai Pulley Trigger FingerStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios S. Nikolaou, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830672
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2020
- First submitted
- 6 Jul 2016
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
- ClinicalTrials.gov ID
- NCT02830672
- Acronym / sponsor ID
- 1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgical release A1 Pulley | Active comparator | Procedure: Surgical release A1 pulley for Trigger finger of the hand |
| Ultrasound guided close release A1 pulley | Active comparator | Procedure: Surgical release A1 pulley for Trigger finger of the hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.
Key exclusion criteria (2 listed)
- Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
- Patients with multiple trigger fingers
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 |
|---|---|---|
| Surgical release A1 pulley for Trigger finger of the hand | Procedure or surgery | Open surgical release A1 Pulley, Ultrasound guided close release A1 pulley |
Primary outcome
Resolution of triggering expressed as the "success rate" per digit.
Time frame: 12 weeks
5 secondary outcomes
The time for taking postoperative pain killers
Time frame: 12 weeks
Range of motion recovery
Time frame: 12 weeks
QuickDASH test scores (Greek version)
Time frame: 12 weeks
Time to return to normal activities (including work)
Time frame: 12 weeks
Cosmetic results
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surgical release A1 pulley for Trigger finger of the hand in people with Surgical Release of Ai Pulley Trigger Finger, run by National and Kapodistrian University of Athens.
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 1 inclusion and 2 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of triggering expressed as the "success rate" per digit. (time frame: 12 weeks). 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 27 Feb 2020.