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NCT Number: NCT06788847

Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture

This study aims to evaluate the efficacy and safety of ultrasound-guided needle knife dissection in treating Dupuytren's contracture. The procedure is designed to improve hund function and minimize complications associated with the conventional surgical methods.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location status: Recruiting

Location contact

Mohamed Maher Elashmawy, MD, PHD.

CONTACT

[email protected]

+201004303100

About this study

Dupuytren's contracture is a disease mainly characterized by the progressive fibrosis of the palmar fascia with subsequent hand deformity and dysfunction. The current study seeks to explore, through this minimally invasive technique, ultrasound-guided needle knife dissection regarding ROM and patient satisfaction. The procedure will be carried out under ultrasound guidance to ensure safety and completeness with the accuracy of precise dissection. Primary outcome measures will concern hand mobility, and secondary measures will evaluate patient self-reported satisfaction and any complications for the 6-month follow-up period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants diagnosed with Dupuytren's Contracture.
  • Willing to undergo ultrasound-guided needle knife dissection

Exclusion criteria

  • Patients who have undergone previous surgery or needle apponeurotomy for Dupuytren's Contracture on the same hand.
  • Active hand infections, open wounds, or dermatological conditions in the treatment area.
  • Coagulopathy or use of anticoagulant that cannot be safely paused
  • Neuromuscular disorders affecting hand function
  • Pregnancy or breastfeeding
  • Uncontrolled systemic illnesses, such as poorly managed diabetes or cardiovascular disease.
  • Known hypersensitivity to local anesthetics.

Treatment and study plan

Ultrasound guided needle knife dissection

Procedure

This procedure involves a minimally invasive dissection of the fibrous cords in Dupuytren's Contracture using a needle knife guided by ultrasound imaging. Local anesthesia using 3-5 ml of 1% Lidocaine and 0.25% bupivacaine is administered for patient comfort. The technique aims to improve precision, minimize complications and reduce recurrence.

Device: Sonosite M-Turbo Ultrasound Machine with Linear Probe HFL38x (6-13 MHz) is used for real-time imaging during the procedure.

Other names: UGNK procedure

Primary outcomes

  1. Improvement in hand Function

    Time frame: 6 months

    Functional Improvement:

    • Evaluated using the QuickDASH score (0-100 scale).
  2. Improvement in hand mobility

    Time frame: 6 months

    Range of Motion (ROM):

    • Measurment of joint mobility in degrees at MCP and PIP joints by goniometer.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 6 months

    Evaluation of patient-reported satisfaction using a standardized questionnaire.

  2. Rate of procedure-related complications

    Time frame: 6 months

    Monitoring and documentation of procedure-related complications, including infection, nerve injury, and other adverse events.

Study contacts

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

Mohamed Maher Elashmawy, MD, PHD.

CONTACT

[email protected]

+201004303100

Sponsors and collaborators

Lead sponsor

Mohamed Maher Ismail Ahmed Elashmawy

Other

Registry information

Official study title

Advancing Dupuytren's Contracture Treatment: a Clinical Prospective Study on Ultrasound-Guided Needle Knife Dissection

Acronym: DC-US

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Jan 27, 2025

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.

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