A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.

NCT ID: NCT06267105

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Disturbance as Result

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Longitudinal incision

Incision performed longitudinally

Group Type EXPERIMENTAL

Longitudinal incision

Intervention Type PROCEDURE

Incision performed longitudinally

Transverse incision

Incision performed transversally

Group Type EXPERIMENTAL

Transverse incision

Intervention Type PROCEDURE

Incision performed transversally

Interventions

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Longitudinal incision

Incision performed longitudinally

Intervention Type PROCEDURE

Transverse incision

Incision performed transversally

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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...).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Corona Poy

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Parc taulĂ­

Sabadell, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mireia Vinas

Role: CONTACT

+34 93 723 10 10 ext. 21652

Facility Contacts

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Mireia

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30852960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31272265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26926477 (View on PubMed)

Other Identifiers

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A1-LORT

Identifier Type: -

Identifier Source: org_study_id

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