Dupytren’s disease study

INTERVENTION: Trade Name: Clostridium Histolyticum (Xiapex) Product Name: Xiapex Pharmaceutical Form: Powder and solvent for solution for injection CONDITION: Dupytren’s disease, primary MCP joint contractures of the third, forth and fifth finger of the hand. ; MedDRA version: 14.1 Level: LLT Classification code 10009904 Term: Collagen disorder NOS System Organ Class: 100000004859 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Therapeutic techniques [E02] PRIMARY OUTCOME: Main Objective: A prospective randomized open label trial comparing the treatment results following injections of Clostridium Histolyticum with that of needle aponeurotomy for patients that have not been treated on the involved hand. With focus on the functional results and risks for complications and recurrence of the contracture. Primary end point(s): Correction of the contracture in degrees constitutes the primary endpoint and will be measured by a manual finger goniometer at follow‐up Secondary Objective: Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. ; In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow‐up by a Jamar dynamometer Timepoint(s) of evaluation of this end point: 1,4 week and 1,2 and 5 years SECONDARY OUTCOME: Secondary end point(s): Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow‐up by a Jamar dynamometer Timepoint(s) of evaluation of this end point: 1,4 week and 1,2 and 5 years INCLUSION CRITERIA: • 30 ° or more contracture of one MCP‐joint (3. ‐5. Finger) • Less than 20 ° contracture of adjacent PIP joint • Single hand involvement • Primary contracture (not operated or treated hand earlier for this condition) • Patients 18 years or older. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40