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Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02474576
Acronym
APADUP
Enrollment
130
Registered
2015-06-17
Start date
2015-09-30
Completion date
2020-04-30
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren Disease

Brief summary

The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known. This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.

Interventions

PROCEDUREPercutaneous aponeurotomy

The finger(s) with limited extension due to Dupuytrens disease and for which the patient desires treatment, will be treated by fine-needle percutaneous aponeurotomy under local anesthesia (outpatient procedure). This procedure is already routinely used in clinical practice ; our study aims at better describing the time-sustainability of its benefits.

Sponsors

Groupe Hospitalier Diaconesses Croix Saint-Simon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient suffers from Dupuytren disease * Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint * Patient has chosen to benefit from local treatment

Exclusion criteria

* Pregnancy * Breastfeeding * No social insurance

Design outcomes

Primary

MeasureTime frameDescription
Frequency of local relapse at 24 months24 months after treatment by aponeurotomythe statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Local relapse is defined as the recurrence of a finger flessum superior by 20° to the articular range initially obtained after aponeurotomy

Secondary

MeasureTime frameDescription
Primary success rate of aponeurotomy3 months after treatmentthe statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Complete success is defined as a finger flessum inferior to 5°
Frequency of local relapse at 12 months12 months after treatment by aponeurotomy
Frequency of local relapse at 36 months36 months after treatment by aponeurotomy
Frequency of local relapse at 48 months48 months after treatment by aponeurotomy
Frequency of local relapse at 60 months60 months after treatment by aponeurotomy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026