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

Clinical Study to Compare Functional Results in Patients Affected by Trigger Finger When Surgery is Performed Through a Transverse or Longitudinal Surgical Incision in the Skin.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Disturbance as Result
• Intervention / Treatment: Procedure: Longitudinal incision; Procedure: Transverse incision

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireia Vinas; Phone Number: 21652 +34 93 723 10 10; Email: mmvinas@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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...).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Longitudinal incision; Incision performed longitudinally	Procedure: Longitudinal incision; Incision performed longitudinally
Experimental: Transverse incision; Incision performed transversally	Procedure: Transverse incision; Incision performed transversally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon comfort	Ecellent, good, poor	Immediately after surgery
Resolution	Presence or absence of engagment	1, 3 and 6 months
Flushed	Red or not red	1, 3 and 6 months
Pain feeling	EVA scale from 0 to 10, being 10 a lot of pain	1, 3 and 6 months
Contracture	Range of motion in degrees	1, 3 and 6 months
Infection	Septic signs such the area is red, hot, swelling or has drain pus	1, 3 and 6 months
Nerve injury	Allen test to evaluate correct circulation, the hand should turn white when pressing	1, 3 and 6 months
Return to work	How many weeks after surgery	1, 3 and 6 months
Reincorporation to activities	How many weeks after surgery	1, 3 and 6 months
Sensitivity Test	In a scale from 0 to 10	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: A1-LORT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No