Dupuytren's Disease
Conditions
Brief summary
The aim of this study is to investigate the potential use of the MiniFlo (CitiEffe) progressive distraction external fixator in the treatment of advanced Dupuytren's disease.
Interventions
DEVICEMiniFlo
MiniFlo distraction for the restoration of finger extension
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
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
* Dupuytren's disease * Age ≥ 18 years * Informed consent
Exclusion criteria
* Age \< 18 years * Pregnancy * Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extension deficit angle (degree) | 12 months | Evaluation of extension deficit angle of fingers affected before and after the treatment. Min 0° (no deficit), Max 180° (high stage disease) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collagenase adverse effects | 12 months | Assessment of potential adverse effects related to the use of collagenase |
| NRS scale | 12 months | Evaluation of pain before and after the treatment. Min 0 (no pain), Max 10 (maximum pain) |
Countries
Italy
Outcome results
None listed