Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture

Not Applicable

Recruiting

• Conditions: Dupuytren Contracture

• Registration Number: NCT06788847
• Lead Sponsor: Mohamed Maher Ismail Ahmed Elashmawy

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study Start: 2025-01-19
• Study First Posted: 2025-01-23
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-07-19
• Study Completion: 2026-01-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in hand Function	6 months	Functional Improvement: - Evaluated using the QuickDASH score (0-100 scale).
Improvement in hand mobility	6 months	Range of Motion (ROM): - Measurment of joint mobility in degrees at MCP and PIP joints by goniometer.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt