Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register

A prospective, non-interventional, observational study using Xiapex® for Dupuytren’s disease named XIANIS was conducted between 1.10.2011 and 01.10.2017. Treatment was conducted in accordance to the manufacturer information. Patients were invited for follow-up after 1 week, 1 month, 3 months and 1 year. Demographic data, treatment data, pain levels, anaesthetic application during passive manipulation, subjective function improvement, subjective satisfaction and adverse events were recorded.

788 patients with 814 treatments were included who suffered from Dupuytren’s contracture for a mean of 64 months. The metacarpophalangeal joint was affected in 57% of cases and the PIP joint in 40.8% with a mean contracture of 39° and 56°, respectively. A change in the contracture down to 0°–5° was reported in 66.5% of cases, while 25.5% achieved a partial improvement. The pain during the injection was rated 4.5 and 3.3 during passive manipulation. Adverse events were reported in the majority of treated patients with skin tears being one main common event (26%). Further adverse outcomes were bleeding/hematoma, joint swelling, injection-site swelling, pressure sensitivity, erythema, injection-site pain, peripheral edema, blood blisters, blisters, painless lymphadenopathy, painful lymphadenopathy, axillary pain, arthralgia and sensory abnormality. There were no reported tendon ruptures, anaphylactic reactions or ligament injuries. On 1-year follow-up, 29% showed an increased contracture of a mean of 24° with the need for surgical treatment in 2% of patients. 74% of patients were very satisfied and 72% showed a high functional improvement.