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

Not Applicable

Recruiting

• Conditions: Functional Disturbance as Result
• Interventions: Procedure: Longitudinal incision; Procedure: Transverse incision

• Registration Number: NCT06267105
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-20
• Study Start: 2024-05-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Longitudinal incision	Longitudinal incision	Incision performed longitudinally
Transverse incision	Transverse incision	Incision performed transversally

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Parc taulí; 🇪🇸 Sabadell, Barcelona, Spain