Natural Disease Progress of Dupuytren Disease

NCT ID: NCT01923103

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 261 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-22
• Study Completion Date: 2023-03-20

Brief Summary

Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown.

The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.

Detailed Description

Objective:

• Primary objective: To study natural disease progress of Dupuytren Disease (DD) in different stages of disease in males and females above 18 years of age.
• Secondary objectives:

1. To study the effect of potential risk factors for DD on natural disease progress.

2. To study at what stage of disease patients with DD experience problems in daily life.

3. To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time.

4. To study the intrarater reliability of the measurements

f. To determine whether the echogenicity of the nodules can predict progression g. To determine whether extension deficit measurements can be replaced by measurements of extension, and whether this will facilitate the statistical analysis h. To determine the association between passive and active measurements of extension and extension deficit, and to see whether active measurements can be derived from passive measurements and vice versa.

• Study design: The study is designed as a prospective observational pilot study with a follow-up of 10 years.
• Study population: Males and females above 18 years of age with all stages of primary Dupuytren's disease in at least one hand
• Main study parameters/endpoints: The natural course of progression of DD measured as the increase or decrease in size of nodules and cords in millimetres and/or increase of total passive extension deficit in degrees, from baseline to endpoint.
• Secondary study parameters:

1. Patient-reported hand function (Michigan Hand Outcomes Questionnaire (MHOQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and Unité Rhumatologique des Affections de la Main (URAM) scale

2. incidence and course of recurrent disease

3. disease activity (ultrasonography and tonometry)

• Procedure Patients visit the outpatient clinic every 6 months (first 5 years of follow-up) and later on every 12 months (last 5 years of follow-up) for an anamnestic interview, physical examination of the hands, ultrasonography, tonometry and for filling out the PROMs.

Conditions

Dupuytren Contracture; Disease Progression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients (> 18 years of age) with primary Dupuytren's disease in all Tubiana stages
• Operated hands of patients with primary Dupuytren's disease on the contra lateral hand

Exclusion Criteria

• Patients who are incapable of giving consent
• Patients who are not able or not willing to visit the UMCG for follow-up
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

D.C. Broekstra

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul MN Werker, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

NDPDD

Identifier Type: -

Identifier Source: org_study_id