Clinical trial NCT06281509: Palmaris Longus Muscle and Dupuytren
Official title: The Potential Relationship Between the Palmaris Longus Muscle Prevalence and Dupuytren Disease: a Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dupuytren's Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Patients with Dupuytren Disease and healthy control group. They will be age matched (50 years of age or higher) with the objective to have a proportionate division (50/50) between the genders.
Primary purpose: DIAGNOSTIC

Brief summary: Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition.

Detailed description: Dupuytren disease is also known as Dupuytren contracture. It is a medical condition characterized by the painless formation of nodules in the palm of the hand. As the disease progresses, approximately 21% - 50% of all patients experience a transformation of these nodules (stage 0/N of Tubiana) into cord-like structures. These cords, in turn, lead to finger contractures (Tubiana stages 1-4) with impairment of hand mobility and stiffening of the palmar skin. The cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition. Interestingly, prior research has already explored this topic. Despite the publication dating back to 1986, it reported a significantly higher occurrence of the palmaris longus tendon in patients affected by DD. Furthermore, a second article from the same year concluded a significant decrease in recurrence when the palmaris longus tendon was resected in combination with regional fasciectomy. Remarkably, no other research on this topic was found despite the promising results of both articles.

Eligibility criteria: Inclusion Criteria:

* The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment.
* 50 years of age or higher.
* Has Dupuytren disease (primary or recurrent). (Only applicable for participants of DD group)
* Has no medical conditions affecting the function of the hand (musculoskeletal pathology, vascular or neurological conditions such as CRPS, rheumatoid arthritis and paralysis). (Only applicable for participants of control group)

Exclusion Criteria:

* Patients \< 50 years
* Patients with cognitive impairments.
* Patients showing signs of medical conditions affecting the function of the hand (musculoskeletal pathology, vascular or neurological conditions such as CRPS, rheumatoid arthritis and paralysis). (Only applicable for participants of control group)

Primary outcomes:
measure: PLM in the DD versus control
timeFrame: Baseline
measure: PML in mild versus severe DD-group
timeFrame: Baseline
Secondary outcomes:
measure: PLM presence in DD affected group
timeFrame: Baseline
measure: PLM presence in control group
timeFrame: Baseline
measure: Dominant versus non-dominant hand
timeFrame: Baseline
measure: Male versus female population
timeFrame: Baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ilse Degreef, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: