Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence (Micronerves)

Observational Study on Small Nerve Bundles in Dupuytren Disease and the Impact of Its Dissection on Recurrence.

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.

Study Overview

• Status: Recruiting
• Conditions: Dupuytren's Disease
• Intervention / Treatment: Procedure: Microfasciectomy

Detailed Description

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 restricitions. Finger movement can be restored by surgery (removing the fibrosis tissue), but recurrence is a major problem (reports of >70%) and this is difficult to treat.

Through microfasciectomy, the presence of small nerve bundles (micronerves) were observed in the finger (other than the digital nerves) through microsurgical enlargement. These nerves are possibly related to the hand fascia, which is the origin of DD. Palmaris fascia innervation was recently elucidated in 16 cadavers and recent research had demonstrated that the palmar aponeurosis is densely innervated and contains a variety of sensory corpuscles as wall as free nerve endings.

These micronerves and their dissection could play a role in the recurrence of DD. This thought is substantiated by the fact neuromas (formed by transection of nerves) were found in recurrence DD and nerve damage is generally known to cause fibrosis (as seen in chronic reactive pain syndrome). This study will investigate the role of these micronerves in DD, the impact of its dissection on formation of neuromas and on recurrence.

It's an observational study, investigation 2 groups of patients. Group 1 being patients with primary DD and group 2 patients with recurrence DD. The nerves and possible neuromas will be documented (presence, location, numbers and (unavoidable) micronerve transections) on a standard map and by digital photomicrography in both groups. The first aim is to confirm their presence and their proximity to the DD fibrosis tissue. Secondly, these allocations will be statistically correlated with clinical outcome and compared between the 2 groups. The ultimate goal of these mappings is to develop new surgical techniques that avoid cutting there nerves and/or cut them at preferable locations (away from recurrence, most likely more proximal at a distance to the proximal interphalangeal joints). Hereby an improved surgical technique (microfasciectomy) can possible reduce/avoid neuroma formation, pain and possibly recurrence.

Also, the presence of nerve growth factor (NGF) will be evaluated. The purpose is to provide information on potential neuro-induced fibrosis. NGF is a cell signalling cytokine that was demonstrated earlier to be associated with nerve tissue, neuromas and pain level. It is linked to the alpha-smooth actin expressing myofibroblast, 'activated' connective tissue cells with contractile properties producing collagen strands that cause the finger contractures. Therefore, the presence of NGF and myofibroblast cells crowd around NGF foci will be studied in a biopsy taken per-operatively. Focus will be on the direct environment of the neuromas. The presence of NGF will also be quantified and compared between both groups. It there is a higher amount of NGF in recurrence, there is a possible role for neuro-induced fibrosis and this creates opportunities to select this protein as a target of treatment to improve clinical outcome.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Ilse Degreef, Prof. Dr.; Phone Number: +32 16 33 88 43; Email: ilse.degreef@uzleuven.be
• Study Contact Backup: Name: Anna Tarasiuk; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitaire Ziekenhuizen KU Leuven
      • Contact: Ilse Degreef, Prof. Dr.; Phone Number: +32 16 33 88 43; Email: ilse.degreef@uzleuven.be
      • Contact: Anna Tarasiuk; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be
      • Principal Investigator: Ilse Degreef, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

1. The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment
2. Participants are ≥ 18 years and diagnosed with primary/recurrent Dupuytren disease
3. Included patients are eligible for microfasciectomy

Exclusion criteria:

Participants eligible for this study must not meet any of the following criteria:

1. Patients < 18 years
2. Patient included in an interventional trial with an investigational medicinal product
3. Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Dupuytren disease; 50 patients with primary Dupuytren disease that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique	Procedure: Microfasciectomy; Using the microscope in Dupuytren's surgery
Recurrence Dupuytren disease; 30 patients with recurrence Dupuytren disease that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique	Procedure: Microfasciectomy; Using the microscope in Dupuytren's surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of neuromas, NGF, αSMA and S100	Presence of neuromas, NGF, αSMA and S100 in Dupuytren nodules after resection.	During surgery/microfasciectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of micronerves	The presence of micronerves with micro-anatomical description in the digital palmar fascia and their relation to the Dupuytren tissue.	During surgery/microfasciectomy
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 functionalityVisual Analogue Scale (VAS) questionnaire on satisfactionVisual Analogue Scale (VAS) questionnaire on pain	pre-operative, post-operative (10 days, 3 months, 12 months)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ilse Degreef, Prof. Dr., Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Skin and Connective Tissue Diseases; Dupuytren Contracture
• Other Study ID Numbers: S68137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No