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Background: To date, real-life data on non-surgical correction of Dupuytren's contracture with collagenase clostridium histolyticum injection (CCH, Xiapex®) are limited. Methods and results: In an open-label non-interventional study in 87 patients in Germany (mean age 65.1±9.8 years, 79.3% males), patients were followed up until 1 year after injection. 63 (73.3%) received the injection at the MCP joint, and 23 (26.7%) at the PIP. The mean grade of contracture in the presently treated finger at baseline was for the MCP joint 32.4°±25.1, for the PIP° 29.2±31.5, and for the DIP° 0.5±2.0. At days 30/360 compared to baseline, the degree of contracture of the MCP joint was reduced by 28.2°±24.6/30.8°±25.0, of the PIP by 20.0°±24.7/8.5°±29.6, and of the DIP by 0.01°±1.9/0.7±2.3. Improvement of hand function at day 30/360 was rated by physicians as very good in 69.5/60.9%, as good in 23.2/28.3%, and as poor in 7.3/8.7%, and none in 0.0/2.2%. No serious adverse drug reactions (SADR) occurred. Adverse drug reactions (ADR) were noted within 24 hours injection in 64 patients (74.4%), mostly contusion/swelling, pain, blood blister or other bleeding at the injection site, or ecchymosis. In an overall assessment, at day 30/360, 73.5%/95.7% of the physicians rated tolerability of CCH in their patients as very good, 22.9%/2.2% as good, and 3.6%/2.2% as moderate. On the EQ-5D Visual Analog Scale the mean score improved from 79.5±17.9 to 83.8±15.8 at day 30, and to 85.4±14.1 at day 360. On the Michigan Hand Questionnaire, the total score was 67.5 points at baseline, 75.7 points at day 30 and 75.2 points at day 360.Conclusions: Overall, treatment with CCH under clinical practice conditions was effective and well tolerated. Quality of life and hand function improved substantially. No unknown safety issues were identified during the study., Hintergrund: Daten zur medikamentösen Behandlung des Morbus Dupuytren mit mikrobieller Kollagenase aus Clostridium histolyticum (Xiapex®) fehlen bisher weitgehend in der klinischen Praxis. Methoden und Ergebnisse: In einer offenen nicht-interventionellen Studie an 87 Patienten in Deutschland wurden die Patienten (mittleres Alter 65,1±9,8 Jahre, 79,3% Männer) bis zu einem Jahr nach der Behandlung mit mikrobieller Kollagenase dokumentiert. 63 (73,3%) Patienten erhielten die Injektion am Metacarpophalangealgelenk (MCP) und 23 (26,7%) am proximalen Interphalangealgelenk (PIP). Zu Studienbeginn war der Kontrakturgrad am behandelten Finger am MCP-Gelenk 32,4°±25,1, am PIP-Gelenk 29,2°±31,5 und am distalen Interphalangealgelenk (DIP) 0,5°±2,0. Im Vergleich zum Ausgangswert wurde bis zu den Tagen 30 bzw. 360 der Kontrakturgrad reduziert: am MCP-Gelenk um 28,2°±24,6 bzw. 30,8°±25,0, am PIP um 20,0°±24,7 bzw. 8,5°±29,6, und am DIP um 0,01°±1,9 bzw. 0,7±2,3. Die Verbesserung der Handfunktion an den Tagen 30 bzw. 360 wurde von Ärzten als sehr gut in 69,5% bzw. 60,9%, als gut in 23,2% bzw. 28,3%, und als schlecht in 7,3% bzw. 8,7%, und als nicht zutreffend in 0,0% bzw. 2,2% bewertet. Es traten keine schwerwiegenden unerwünschten Arzneimittelwirkungen auf. Unerwünschte Arzneimittelwirkungen wurden innerhalb von 24 Stunden nach Injektion bei 64 Patienten (74,4%) dokumentiert, vor allem Schwellungen, Schmerzen, Blutblasen oder andere Blutungen an der Injektionsstelle oder der umgebenden Haut. An den Tagen 30 bzw. 360 stuften 73,5% bzw. 95,7% der Ärzte die Verträglichkeit der mikrobiellen Kollagenase als sehr gut ein, 22,9% bzw. 2,2% als gut, und 3,6% bzw. 2,2% als moderat. Auf der visuellen Analogskala (EuoQol-5D) zeigte sich die Lebensqualität im Vergleich zum Ausgangswert (79,5±17,9) verbessert am Tag 30 (83,8±15,8) bzw. am Tag 360 (85,4±14,1). Die Gesamtpunktzahl des Michigan Hand Questionnaire (MHQ) betrug 67,5 Punkte vor Behandlungsbeginn, 75,7 Punkte am Tag 30 und 75,2 Punkte

The aim of this study was to determine a definition of recurrence of Dupuytren disease that could be utilized for the comparison of the results independently from the treatment used. 24 hand surgeons from 17 countries met in an international consensus conference. The participants used the Delphi method to evaluate a series of statements: (1) the need for defining recurrence, (2) the concept of recurrence applied to the Tubiana staging system, (3) the concept of recurrence applied to each single treated joint, and (4) the concept of recurrence applied to the finger ray. For each item, the possible answer was given on a scale of 1-5: 1=maximum disagreement; 2=disagreement; 3=agreement; 4=strong agreement; 5=absolute agreement. There was consensus on disagreement if 1 and 2 comprised at least 66% of the recorded answers and consensus on agreement if 3, 4 and 5 comprised at least 66% of the recorded answers. If a threshold of 66% was not reached, the related statement was considered "not defined". A need for a definition of recurrence was established. The presence of nodules or cords without finger contracture was not considered an indication of recurrence. The Tubiana staging system was considered inappropriate for reporting recurrence. Recurrence was best determined by the measurement of a specific joint, rather than a total ray. Time 0 occurred between 6 weeks and 3 months. Recurrence was defined as a PED of more than 20° for at least one of treated joint, in the presence of a palpable cord, compared to the result obtained at time 0. This study determined the need for a standard definition of recurrence and reached consensus on that definition, which we should become the standard for the reporting of recurrence. If utilized in subsequent publications, this will allow surgeons to compare different techniques and make is easier to help patients make an informed choice.