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NCT Number: NCT06267105

A Clinical Study to Compare Functional Outcomes After Surgery Using 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Parc taulí

Sabadell, Barcelona, 08208, Spain

Location status: Recruiting

Location contact

Mireia

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...).

Treatment and study plan

Longitudinal incision

Procedure

Incision performed longitudinally

Transverse incision

Procedure

Incision performed transversally

Primary outcomes

  1. Functional improvement of the patient after surgery

    Time frame: 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 outcomes

  1. Surgeon comfort

    Time frame: Immediately after surgery

    Ecellent, good, poor

  2. Resolution

    Time frame: 1, 3 and 6 months

    Presence or absence of engagment

  3. Flushed

    Time frame: 1, 3 and 6 months

    Red or not red

  4. Pain feeling

    Time frame: 1, 3 and 6 months

    EVA scale from 0 to 10, being 10 a lot of pain

  5. Contracture

    Time frame: 1, 3 and 6 months

    Range of motion in degrees

  6. Infection

    Time frame: 1, 3 and 6 months

    Septic signs such the area is red, hot, swelling or has drain pus

  7. Nerve injury

    Time frame: 1, 3 and 6 months

    Allen test to evaluate correct circulation, the hand should turn white when pressing

  8. Return to work

    Time frame: 1, 3 and 6 months

    How many weeks after surgery

  9. Reincorporation to activities

    Time frame: 1, 3 and 6 months

    How many weeks after surgery

  10. Sensitivity Test

    Time frame: 1, 3 and 6 months

    In a scale from 0 to 10

Study contacts

Contact information is provided by the study sponsor or research team.

Mireia Vinas

CONTACT

[email protected]

+34 93 723 10 10 ext. 21652

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.