Natural Disease Progress of Dupuytren Disease

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.

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Key information

Conditions

Dupuytren Contracture Connective Tissue Diseases Contracture Disease Attributes Disease Progression Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

About this study

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:

To study the effect of potential risk factors for DD on natural disease progress.
To study at what stage of disease patients with DD experience problems in daily life.
To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time.
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:

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
incidence and course of recurrent disease
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The course of DD: passive and active extension deficit and dimension of palpable nodules and cords

Time frame: every 6-12 months

Active and passive extension deficit is measured with a goniometer at joint level Dimension of nodules and cords is measured using a tumorimeter

Secondary outcomes

Disease activity: Echogenicity and nodule hardness

Time frame: every 12 months, starting from 2016 (ultrasound) and 2018 (tonometry)

Activity of a nodule is determined by 1) echogenicity of the ultrasound image in sagittal and transversal plane, 2) hardness of the nodule determined by tonometry
Patient-reported hand function: MHQ, PRWHE and URAM

Time frame: every 6-12 months

To study what problems patients with DD experience in daily life, PROMs are used. MHQ and PRWHE in the first 2 years, URAM later on

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: DD

Important dates

Study start: 2012
Primary completion: 2023
Study completion: 2023
First posted: Aug 14, 2013
Registry last updated: Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed