Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture

NCT06788847 | Recruiting

• 2 other identifiers: MansouraUH_DC-US_2025R.24.12.2966
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dupuytren Contracture

Keywords

Ultrasound-Guided Procedure; Dupuytrene's Contracture; Tubiana Grade; Fibrotic Cords Acupotomy; Functional Hand Recovery; Palmar Fascia Fibrosis

Outcome Measures

Primary Outcomes (2)

• Improvement in hand Function

  Functional Improvement: \- Evaluated using the QuickDASH score (0-100 scale).

  6 months

• Improvement in hand mobility

  Range of Motion (ROM): \- Measurment of joint mobility in degrees at MCP and PIP joints by goniometer.

  6 months

Secondary Outcomes (2)

• Patient Satisfaction

  6 months

• Rate of procedure-related complications

  6 months

Study Arms (1)

Intervention Group: Ultrasound-Guided Needle Knife Dissection

EXPERIMENTAL

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

Interventions

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.

Also known as: UGNK procedure

Intervention Group: Ultrasound-Guided Needle Knife Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Maher Ismail Ahmed Elashmawy: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohamed Maher Elashmawy, MD, PHD.

CONTACT

+201004303100; mohamedmaherismail@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Rheumatology, Physical Medicine and Rehabilitation

Model Details: All participants will undergo ultrasound-guided needle knife dissection for Dupuytren's Contracture treatment.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 19, 2025
• Primary Completion: July 19, 2025
• Study Completion: January 19, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)