Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture

NCT ID: NCT06788847

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-19

Study Completion Date

2026-01-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dupuytren Contracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will undergo ultrasound-guided needle knife dissection for Dupuytren's Contracture treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ultrasound guided needle knife dissection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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UGNK procedure

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Maher Ismail Ahmed Elashmawy

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Maher Ismail Ahmed Elashmawy

Lecturer of Rheumatology, Physical Medicine and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Maher Elashmawy, MD, PHD.

Role: CONTACT

+201004303100

Facility Contacts

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Mohamed Maher Elashmawy, MD, PHD.

Role: primary

+201004303100

Other Identifiers

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R.24.12.2966

Identifier Type: REGISTRY

Identifier Source: secondary_id

MansouraUH_DC-US_2025

Identifier Type: -

Identifier Source: org_study_id

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