Treatment of Stage III-IV Dupuytren's Disease With the MiniFlo External Fixator
Phase: NA
Conditions: Dupuytren's Disease
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

TITLE: Proposal for Treatment of Severe Dupuytren Disease in 2 Steps: Progressive Distraction 
With External Fixator and Collagenase - A Preliminary Case Series 
 
NCT ID not yet assigned 
 
DATE: 09/03/2026 
 
 
 

INTRODUCTION 
Dupuytren disease (DD) is characterized by progressive ﬂexion deformity of one or more 
ﬁngers due to a benign proliferation of ﬁbroblasts associated with increased accumulation of 
collagen in the palmar aponeurosis. In the late stages of DD, surgical treatment is challenging 
due to limited anatomical space and soft tissue contracture, increasing the risk of 
complications and incomplete correction. Over the past 10 years, nonsurgical treatments, 
like collagenase, have represented another therapeutic option for managing this as-yet 
incurable disease. For these severe cases, we propose a 2-step technique based on external 
ﬁxation followed by collagenase injection, aiming at extension of the contracted ﬁngers. 
Indications for this treatment are severe DD stages 3 and 4 aWecting no more than 2 ﬁngers, 
even if recurrence, without contracted arthritic joint. 
Due to its dorsal positioning, the device we used is particularly comfortable for patients, 
leaving free the other ﬁnger sides. As for the collagenase, the European Commission’s 
approval for the only formulation available (Xiapex) was obtained in 2010. The product was 
approved in Italy in February 2013 (GU Serie Generale n.49 del 27-02-2013)1, for contractures 
of the metatarsophalangeal joint (MPJ) ranging from 20° to 50° and for contractures of the 
proximal interphalangeal joint (PIPJ) between 15° and 40° (eligibility criteria, source AIFA—the 
Italian Drugs Agency). 
Our proposal for treatment arises from the fact that even if the common algorithm of single 
joint injections with monthly intervals has changed (following multiple reported experiences 
in the medical literature)2, the Italian National Health System covers only the expense for one 
collagenase injection per hand for DD stages 1 and 2. Given that severe DD stages 3 and 4 
generally involve MPJ and PIPJ simultaneously, a single injection is not enough to treat both of 
the articulations1. Therefore, it is mandatory to decrease the severity of the disease; in such 
cases, patients can beneﬁt from a completely public health system–covered treatment. 
 
MATERIALS AND METHODS 
Between October 2014 and September 2016, we performed 22 treatments in 18 patients with 
DD stages 3 and 4 according to the Tubiana classiﬁcation3. Seven cases were recurrences of 
DD previously treated with open aponeurectomy. Informed consent was collected from each 
patient, and approval by our ethics committee was obtained before study initiation (code: 
Miniﬂo-ITAl4) for the use of external ﬁxator (EF) MiniFlo, developed by CitieWe (Bologna, Italy). 
This device is a single-bar articulated transarticular hinged EF, placed dorsally on the aWected 
ﬁngers via 4 self-drilling pins, applied using a percutaneous technique after determination of 
the joint center of rotation. The device is available in 2 diWerent conﬁgurations to treat a single 
aWected joint (PIPJ and MPJ—model R25) or for treatment of both PIPJ and MPJ simultaneously 
(model R30). 

Increasing digital extension was performed by the patients by operating a worm screw in the 
hinge of the EF with a custom wrench. The palmar side of the treated ﬁngers remained free to 
perform daily life activities. Inclusion criteria for participation in the trial were the following: 
adults aged 18 years or older, DD stages 3 to 4, absence of arthritis at MPJ-PIPJ, no more than 
2 ﬁngers treated simultaneously, and patient’s motivation; exclusion criteria were the 
following: mental illness; unwillingness to undergo follow-up visits; DD stage 0, 1, or 2; joint 
ankylosis; and pregnancy and nursing mothers. 
The treatment protocol was the same in all cases and comprised 2 steps: 
Step 1: Fixator Application and Progressive Distraction 
The EF is applied by placing the patients in the supine position in the operating, with the 
aWected limb placed on a radiolucent arm board for ﬂuoroscopy. Local anesthesia (10 mL 
mepivacaine chlorhydrate—20 mg/mL—digital block) is performed in the aWected ﬁngers. The 
choice between the 2 EF models depends on the contraction discrepancy at the MPJ and PIPJ: 
in our cases, if the contraction severity was similar in both of the articulations, we used the 
R30 model to treat them together; the R25 model was used instead to correct a more 
contracted PIPJ compared with a less involved MPJ. In this way, it is also possible to treat a 
“reverse” situation, that is, a more contracted MPJ opposed to a less severe PIPJ. Under 
ﬂuoroscopic control, in lateral view a 1.5-mm Kirschner wire is inserted percutaneously with a 
power drill on the dorsal aspect of the bone: for PIPJ correction, it is directed to the joint 
center of rotation, corresponding to the center of the head of the proximal phalanx in lateral 
view; for simultaneous correction of PIPJ and MPJ, the center of rotation is established by 
considering the bisector of the angle between the axes of the metacarpal and the middle 
phalanx. Hence, the Kirschner wire direction lies approximately on a perpendicular line to the 
middle point of the proximal phalanx in the lateral view. A ruler guide is stored in the device 
container, to be more precise. The EF slides along the Kirschner wire and, once in place, is 
ﬁxed with a self-drilling pin in the most proximal clamp; the second pin is inserted in the distal 
clamp followed by the remaining 2 pins. At the end of the procedure, the Kirschner wire is 
removed. It is important to leave at least 5 mm between the skin and the EF for pin care. 
The patients start progressive extension the day after surgery by turning the worm screw 1 full 
turn a day, corresponding to 3°. Usually, we suggest patients to split the full turn into 2 half 
turns, one in the morning and the other in the evening, for better compliance and pain control. 
Weekly checks are planned to evaluate pain and discomfort and any adverse events and to 
check whether the patients were applying the correct amount of distraction. The EF is 
removed in the outpatient clinic without anesthesia, after reaching a complete device 
extension at an average of 19 days (15-22 days). 
After EF removal and before collagenase injection, all the patients had undergone 
physiotherapy and local skin treatments plus capsuloligamentous stretching, associated with 
splinting and assisted mobilization, for a mean period of 20 days (18-24 days). 

Step 2: Collagenase Procedure 
According to international guidelines Clostridium histolyticum collagenase (Xiapex [Sobi]) is 
injected in the residual palmar MPJ cord in the treated digital ray. The next day, cord rupture is 
obtained by ﬁnger manipulation and distraction under local anesthesia (4 mL mepivacaine 
chlorhydrate—20 mg/mL). Previous distraction with EF considerably decreases the risk of skin 
lacerations after manipulation, a rather common eventuality especially in high-grade 
contractures with tight skin adhesion. 
Subsequently, a customized thermoplastic dorsal traction splint is applied. Patients wear the 
splint for 21 days, around 22 hours a day, whereas the remaining 2 hours are dedicated to 
active and passive ﬁnger mobilization assisted by physical therapist. After that, the splint is 
worn only at night for an additional 6 weeks. 
 
STATISTICAL ANALYSIS PLAN (SAP) 
The study is designed as a preliminary case series without a control group, and the statistical 
analysis is primarily descriptive. Continuous variables, such as angular deformity and 
correction degrees, are summarized using means and ranges, allowing a quantitative 
assessment of treatment eWect across time points (pre-treatment, post–external ﬁxation, and 
follow-up). Pain intensity is evaluated using the Visual Analog Scale (VAS) and similarly 
reported as mean values with ranges. No inferential statistical tests (e.g., hypothesis testing, 
p-values, or conﬁdence intervals) are described, reﬂecting the exploratory nature and limited 
sample size of the cohort. Outcomes are reported longitudinally, with comparisons made 
within subjects over time rather than between groups, and results are presented in tabular 
form to illustrate individual and aggregate changes in joint contracture. 
 

REFERENCES 
1. Agenzia Italiana del Farmaco, determina 12 febbraio 2013—Regime di rimborsabilità e 
prezzo di vendita del medicinale “Xiapex” (collagenasi di clostridium histolyticum)—
autorizzata con procedura centralizzata europea dalla Commissione europea (Determina n. 
170/2013). (13A01767) (GU Serie Generale n.49 del 27-02-2013. http:// 
www.gazzettauWiciale.it/eli/id/2013/02/27/13A01767/sg. Accessed December 19, 2018.  
2. Degreef I. Collagenase treatment in Dupuytren contractures: a review of the current state 
versus future needs. Rheumatol Ther. 2015;3:43-51. 
3. Tubiana R. Evaluation of deformities in Dupuytren’s disease. Ann Chir Main. 1986;5:5-11.