Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing
deformities of the hand. Although numerous treatments exist, the most common and widely
accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery
time, and many patients require multiple surgeries throughout their life as the disease
progresses, with repeat surgeries increasing the risk of complications.
Long recovery times and need for repeat surgeries has renewed interest in minimally invasive
treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid
improvement in finger extension with minimal recovery time. The FDA approved collagenase
clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for
rapid increase in finger extension, also with minimal recovery time. Currently there is only
one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes
in both treatments. Both treatments are minimally invasive, requiring minimal time off work
and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly
in patients with multiple areas of disease requiring treatment. The project proposed will
compare these two methods for treating Dupuytren's disease.
Approximately 334 participants will be recruited from patients referred for treatment to hand
surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be
determined in the usual fashion, and the option for entry into the study will be proposed to
patients meeting inclusion/exclusion criteria. Participants will be randomized into either
the PNA or CI treatment group. The surgeon will not be blinded to the procedure group;
however, the therapist measuring outcomes will be, and the study participants will need to
not divulge to the therapists which group they are in.
Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves
the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle
inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken
it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection
of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to
see the surgeon within one week, has freezing placed in the hand, and the affected digit is
extended to rupture the already weakened cord.
The patient will be required to present to the hand therapist team for measurements of joint
angles before and after the assigned treatment is performed. In order to measure treatment
efficacy, study participants will be required to return for measurements of treated joints
every 6 months. Lastly, participants will need to inform the performing surgeon or therapist,
at follow-up visits of any complications they experience.