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Trial Title:
Palmaris Longus Muscle and Dupuytren
NCT ID:
NCT06281509
Condition:
Dupuytren's Disease
Conditions: Official terms:
Dupuytren Contracture
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Masking description:
No masking will be done in this study
Intervention:
Intervention type:
Procedure
Intervention name:
Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands.
Description:
Schaeffer's test (flexion of the wrist while the pinky and thumb are pressed against each
other) Thompson's test (wrist flexion with a clenched fist) Mishra test I (wrist flexion
while the examiner pushes the hand back) Mashra test II (thumb opposition while flexing
the wrist)
Arm group label:
Healthy controls
Arm group label:
Patients with Dupuytren disease
Intervention type:
Procedure
Intervention name:
Ultrasound
Description:
A small mobile ultrasound device will be used to further asses the presence of the
tendon.
Arm group label:
Healthy controls
Arm group label:
Patients with Dupuytren disease
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.
Criteria for 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)
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Universitaire Ziekenhuizen KU Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ilse Degreef, Prof. Dr.
Phone:
+32 16 33 88 43
Email:
ilse.degreef@uzleuven.be
Contact backup:
Last name:
Anna Tarasiuk
Phone:
+32 16 33 88 18
Email:
orthopedie.research@uzleuven.be
Start date:
February 16, 2024
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281509
