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RecruitingNCT06788847DC-USUpdated Jan 27, 2025

Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture

An interventional study of Ultrasound guided needle knife dissection in Dupuytren Contracture, sponsored by Mohamed Maher Ismail Ahmed Elashmawy. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Mohamed Maher Ismail Ahmed Elashmawy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dupuytren Contracture

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Keywords

  • Ultrasound-Guided Procedure
  • Dupuytrene's Contracture
  • Tubiana Grade
  • Fibrotic Cords Acupotomy
  • Functional Hand Recovery
  • Palmar Fascia Fibrosis
03

In context

Dupuytren Contracture

78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

Mohamed Maher Ismail Ahmed Elashmawy is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 to local anesthetics.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureUltrasound 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.

    Also known as: UGNK procedure

06

What researchers measure

Primary outcomes

  1. Improvement in hand Function

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

    Time frame: 6 months

  2. Improvement in hand mobility

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

    Time frame: 6 months

Secondary outcomes

  1. Patient Satisfaction

    Evaluation of patient-reported satisfaction using a standardized questionnaire.

    Time frame: 6 months

  2. Rate of procedure-related complications

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Jul 2025, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2025
First posted
Jan 23, 2025
StartActual
Jan 19, 2025
Primary completionEst.
Jul 19, 2025
CompletionEst.
Jan 19, 2026
Last update
Jan 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06788847
Lead sponsor
Mohamed Maher Ismail Ahmed Elashmawy
Responsible party
Mohamed Maher Ismail Ahmed Elashmawy (Lecturer of Rheumatology, Physical Medicine and Rehabilitation, Mansoura University Hospital) — Sponsor-investigator
First posted
Jan 23, 2025
Start date
Jan 19, 2025
Primary completion
Jul 19, 2025 (estimated)
Completion
Jan 19, 2026 (estimated)
Last update
Jan 27, 2025

Study contacts

Mohamed Maher Elashmawy, MD, PHD.
Contact
mohamedmaherismail@mans.edu.eg
+201004303100

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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