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· DOS Abstracts
Collagenase clostridium histolyticum (Xiapex®) versus
percutaneous needle fasciotomy for Dupuytren’s
contracture in proximal interphalangeal joints. An
independent, open-label, randomized controlled trial
Simon Toftgaard Skov, Therkel Bisgaard, Per Søndergaard, Jeppe Lange
Center for planned surgery, Regional Hospital Silkeborg; Center for planned sur-
gery, Regional Hospital Silkeborg; Center for planned surgery, Regional Hospital
Silkeborg; Center for planned surgery, Regional Hospital Silkeborg
Background:
Collagenase clostridium histolyticum injection (CI), a new minimal
invasive procedure for Dupuytren’s contracture (DC), emerged in 2009-2011
with promising results. Head-to-head comparison with other active treatments
has not been performed as of today. We hypothesized that CI would show bet-
ter long-term results.
Purpose / Aim of Study:
To compare percutaneous needle fasciotomy (PNF)
to CI with Xiapex®.
Materials and Methods:
The study was performed as a single- center, in-
dependent, open-label, Randomized Controlled Trial. 50 patients with isolated
proximal interphalangeal (PIP) joint DC (≥20 degrees) were enrolled. Patients
received either CI according to the manufacturer guideline or our center stand-
ardized PNF treatment. Patients were followed for 2 years. Primary outcome
was clinical improvement, defined as a reduction in contracture by 50% or
more relative to baseline. Several secondary outcomes were evaluated, includ-
ing change in PIP-joint passive extension deficit (PED), patient satisfaction and
Disability of Arm, Shoulder and Hand questionnaire score.
Findings / Results:
Clinical improvement was achieved in 8% in the CI-group
and 32% in the PNF-group at 2 year follow-up (p=0.05). Secondary clinical
outcome parameters and DASH-scores did not differ significantly. Patient sat-
isfaction at 2 years was poorer in the CI group with a median numerical rating
scale score (0 worst, 10 best) of 1 vs. 7 in the PNF group (p=0.04). A higher
complication rate was found in the CI group.
Conclusions:
We conclude that CI offers no advantages over PNF in isolated
PIP-joint DC. This is the first head-to-head comparison and the first independ-
ent RCT of CI to another active treatment procedure. Confirmation from other
independent studies are needed.
No conflicts of interest reported
89.