Purpose
Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture
following initial phase-3 investigations in 2009 with promising results. However,
the efficacy of CCH has not been prospectively investigated in a direct comparison
to other active treatments of Dupuytren contracture with more than 1-year follow-up,
despite a wide and increasing clinical use.
Method
In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty
patients with primary isolated proximal interphalangeal joint Dupuytren contractures
were enrolled and followed for 2 years. The primary outcome was clinical improvement
defined as a reduction in contracture by 50% or more relative to baseline. Secondary
outcomes included change in contracture, recurrence, adverse events, complications,
and Disabilities of the Arm, Shoulder, and Hand questionnaire score.
Results
Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and
29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the
patients treated with PNF. No other differences were observed.
Conclusions
This study provides evidence that CCH is not superior to PNF in the treatment of isolated
proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and
it led to more complications than PNF.
Type of study/level of evidence
Therapeutic I.
Key words
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Article info
Publication history
Accepted:
March 1,
2017
Received:
October 19,
2016
Footnotes
S.T.S., T.B., and P.S. attended the International 2013 Dupuytren Summit meeting in Vienna, Austria; invited by Pfizer Denmark (transportation and accommodation included). No personal fees or other disclosures for the authors.
Identification
Copyright
© 2017 by the American Society for Surgery of the Hand. All rights reserved.
