Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture (DC-US)

January 23, 2025 updated by: Mohamed Maher Ismail Ahmed Elashmawy

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group: Ultrasound-Guided Needle Knife Dissection
Participants in this group will undergo ultrasound-guided needle knife dissection for the treatment of Dupuytren's Contracture. Local anesthesia using 3-5ml of 1% lidocaine 0.25% bupivacaine is administered for patient comfort. This procedure is designed to improve hand function with minimal complications.
Procedure: Ultrasound guided needle knife dissection

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in hand Function
Time Frame: 6 months

Functional Improvement:

- Evaluated using the QuickDASH score (0-100 scale).
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 6 months
Evaluation of patient-reported satisfaction using a standardized questionnaire.
6 months
Rate of procedure-related complications
Time Frame: 6 months
Monitoring and documentation of procedure-related complications, including infection, nerve injury, and other adverse events.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Maher Ismail Ahmed Elashmawy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2025

Primary Completion (Estimated)

July 19, 2025

Study Completion (Estimated)

January 19, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MansouraUH_DC-US_2025
  • R.24.12.2966 (Registry Identifier: Mansoura University Faculty of Medicine IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) will not be shared to ensure participant confidentiality and comply with ethical and institutional regulations. The collected data will only be used for the purposes of this study and will not be disclosed to external parties

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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