NCT06267105

Brief Summary

Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

January 31, 2024

Last Update Submit

August 13, 2024

Conditions

Functional Disturbance as Result

Outcome Measures

Primary Outcomes (1)

  • Functional improvement of the patient after surgery

    functional improvement of the patient after surgery, which will be assessed with the Dash scale, 1 being difficult while 5 being unable

    Immediately after surgery

Secondary Outcomes (10)

  • Surgeon comfort

    Immediately after surgery

  • Resolution

    1, 3 and 6 months

  • Flushed

    1, 3 and 6 months

  • Pain feeling

    1, 3 and 6 months

  • Contracture

    1, 3 and 6 months

  • +5 more secondary outcomes

Study Arms (2)

Longitudinal incision

EXPERIMENTAL

Incision performed longitudinally

Procedure: Longitudinal incision

Transverse incision

EXPERIMENTAL

Incision performed transversally

Procedure: Transverse incision

Interventions

Longitudinal incisionPROCEDURE

Incision performed longitudinally

Longitudinal incision
Transverse incisionPROCEDURE

Incision performed transversally

Transverse incision

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age.
  • Clinical diagnosis of trigger finger grade II to IV.
  • Grade I (pre-trigger) Pain, history of entrapment, but not demonstrable on physical examination, tenderness over the A1 pulley.
  • Grade II (active) Demonstrable entrapment, but the patient can actively extend the finger.
  • Grade III (passive) Demonstrable entrapment, patient requires passive extension IIIA or inability to actively flex IIIB.
  • Grade IV (contracture) Demonstrable entrapment with fixed flexion contracture of the PIP.

You may not qualify if:

  • Thumb
  • Polydigital
  • Allergy to local anesthetics and/or vasoconstrictor agents.
  • Previous surgery
  • Patients who, in the researcher's opinion, are not good candidates for the study (e.g. inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug or alcohol abuse problems...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Parc taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (3)

  • Mohd Rashid MZ, Sapuan J, Abdullah S. A randomized controlled trial of trigger finger release under digital anesthesia with (WALANT) and without adrenaline. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019833002. doi: 10.1177/2309499019833002.

    PMID: 30852960BACKGROUND

  • Kazmers NH, Holt D, Tyser AR, Wang A, Hutchinson DT. A prospective, randomized clinical trial of transverse versus longitudinal incisions for trigger finger release. J Hand Surg Eur Vol. 2019 Oct;44(8):810-815. doi: 10.1177/1753193419859375. Epub 2019 Jul 4.

    PMID: 31272265BACKGROUND

  • Kloeters O, Ulrich DJ, Bloemsma G, van Houdt CI. Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation. Arch Orthop Trauma Surg. 2016 May;136(5):731-7. doi: 10.1007/s00402-016-2430-z. Epub 2016 Feb 29.

    PMID: 26926477BACKGROUND

Central Study Contacts

Mireia Vinas

CONTACT

+34 93 723 10 10mmvinas@tauli.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 20, 2024

Study Start

May 15, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)