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Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence

ConditionDupuytren's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

Dupuytren disease (DD) is a highly prevalent disabling hand disease. Spontaneous fibrosis nodules and strands in the palms of the hand cause finger contractures in disturbing positions and movement restrictions. Finger movement can be restored by surgery (removing the fibrosis tissue), but recurrence is a major problem and this is difficult to treat.

Through microfasciectomy, the presence of small nerve bundles (micronerves) were observed. These nerves are possibly related to the hand fascia, which is the origin of Dupuytren disease. These micornerves and their dissection could play a role in the recurrence of DD. This study will investigate the role of these micronerves in DD, the impact of its dissection on formation of neuromas and on recurrence.

Also, the presence of nerve growth factor (NGF) will be evaluated. The purpose is to provide information on potential neuro-induced fibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment

Participants are ≥ 18 years and diagnosed with primary/recurrent Dupuytren disease

Included patients are eligible for microfasciectomy

Disqualifiers

Patients < 18 years

Patient included in an interventional trial with an investigational medicinal product

Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers

Trial population

Patients older than 18 years old that present with Dupuytren disease (primary or recurrence) and that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Microfasciectomy

    Procedure/Surgery

    Using the microscope in Dupuytren's surgery

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Primary Dupuytren disease1 intervention
Group B: Recurrence Dupuytren disease1 intervention

Trial outcomes

Primary outcomes

1

Presence of neuromas, NGF, αSMA and S100

Presence of neuromas, NGF, αSMA and S100 in Dupuytren nodules after resection.

Time frame
During surgery/microfasciectomy

Secondary outcomes

1

Presence of micronerves

The presence of micronerves with micro-anatomical description in the digital palmar fascia and their relation to the Dupuytren tissue.

Time frame
During surgery/microfasciectomy
2

Correlate clinical outcome (motion, pain, recurrence) with these findings (micronerve dissection, presence of neuromas, NGF and αSMA) in both groups

* Objective clinical outcome: * Range of motion (by goniometry of Distal interphalangeal, Proximal Interphalangeal and metacarpophalangeal joints) * Abe. diathesis scoring * Patient reported outcome: * QUICK Dash for functionality * Visual Analogue Scale (VAS) questionnaire on satisfaction * Visual Analogue Scale (VAS) questionnaire on pain

Time frame
pre-operative, post-operative (10 days, 3 months, 12 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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