Ultrasound Guided A1 Pulley Release For The Treatment of... | NCT02830672

Studies
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger

NCT02830672

Sponsor

National and Kapodistrian University of Athens

Status

Completed

Last Update Posted

Feb 27, 2020Actual

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Surgical Release of Ai Pulley Trigger Finger

Interventions

Surgical release A1 pulley for Trigger finger of the hand

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Oct 1, 2016Actual

Completion Date

Dec 1, 2016Actual

First Submitted Date

Jul 6, 2016

First Submission Date that Met QC Criteria

Jul 9, 2016

First Posted Date

Jul 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2020

Last Update Posted Date

Feb 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vasileios S. Nikolaou, Assistant Professor Of Orthopedics, National and Kapodistrian University of AthensPrincipal Investigator

Lead Sponsor

National and Kapodistrian University of AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical release A1 pulley for Trigger finger of the hand	Procedure		Open surgical release A1 Pulley Ultrasound guided close release A1 pulley

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of triggering expressed as the "success rate" per digit.		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
The time for taking postoperative pain killers		12 weeks
Range of motion recovery		12 weeks
QuickDASH test scores (Greek version)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided