Satisfaction and Recovery After Trigger Finger Release | NCT05336045

Studies
Satisfaction and Recovery After Trigger Finger Release

NCT05336045

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Trigger Finger Disorder

Interventions

trigger finger release

Countries

Sweden

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

Nov 2023

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

Apr 26, 2022Actual

Primary Completion Date

Nov 26, 2024Actual

Completion Date

Nov 26, 2024Actual

First Submitted Date

Apr 6, 2022

First Submission Date that Met QC Criteria

Apr 12, 2022

First Posted Date

Apr 20, 2022Actual

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

Nov 26, 2024

Last Update Posted Date

Nov 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joakim Stromberg, senior consultant surgeon, MD, PhD, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Trigger finger release is one of the most common procedures in hand surgery. However, little is known about the patient perceived outcome directly after surgery and the timespan to recovery of normal hand function.This study focuses on patient reported outcome scores within the first six weeks after surgery.

Detailed Description

Patients scheduled for release of trigger finger are assessed regarding the following outcome measures:

VAS score for pain
VAS score for finger movement
VAS score for fréquence of triggering
HAKIR questionnaire (validated instrument for hand function in the Swedish national hand registry)
Quick-DASH questionnaire.

After surgery, the patients records the following outcomes:

Each day: 1,2,3 and records of pain medication details Each week: 4,5

for 6 weeks

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trigger finger release	Procedure	The A1 pulley and tendon sheath is divided in local anaestethic through a small incision in the palm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-assessed hand function	change in total score of hand-specific questionnaire (HAKIR) week by week. Best score 100, worst 0	every week for 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pain (assessed by patient)	change in Visual Analouge Scale-score day by day (0= worst, 10=best)	6 weeks
Movement of finger (self-assessed by patient)	change in Visual Analouge Scale-score day by day (0= worst, 10=best)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Trigger phenomenon and/or
Tenderness volarly to MCP joint of affected finger/thumb
Patient scheduled for trigger finger release
Signed informed consent

Exclusion Criteria:

Concomitant hand injuries/ conditions
Multiple fingers/thumbs to be treated
Unable to read/understand instructions in Swedish

Accepts Healthy Volunteers

Yes

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

Patient scheduled for trigger finger release

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

open repositry

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052582	Trigger Finger Disorder

Ancestor Terms

ID	Term
D053682	Tendon Entrapment
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

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Browse Branches

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