Dupuytren's contracture MedDRA version: 19.1 Level: PT Classification code 10013872 Term: Dupuytren's contracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.1 Level: PT Classification code 10013873 Term: Dupuytren's contracture operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Xiapex
Product Name: Xiapex
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Collagenase Clostridium Histolyticum
CAS Number: 9001-12-1
Concentration
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or Female and aged 18 years or over • Presence of discrete, palpable, contracted cord involving the metacarpophalangeal joint and/or proximal interphalangeal joint of a finger • Degree of contracture >30 degrees in either joint i.e. patient cannot put the palm of the hand flat on a table (Hueston’s Tabletop test) • Able to identify a predominant finger for treatment which would not require more than one collagenase injection as treatment for a single cord • Appropriate for limited fasciectomy and collagenase injection for Dupuytren’s contracture (i.e. not requiring skin grafting or PNF (eg discrete MCP cords in elderly)) • Patient is willing and able to give informed consent for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 639 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 71
Exclusion criteria
Exclusion criteria: • Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4) • History of previous intervention for Dupuytren’s contracture (e.g. limited fasciectomy, collagenase injection or needle fasciectomy) on the same hand • History of any other pre-existing disorder of the hand causing restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis • Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages • Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible • Contraindicated for use of Collagenase • Any other significant disease or disorder (including autoimmune disorders) which, in the opinion of the Investigator, may put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants who have participated in another research study involving an investigational product in the past 12 weeks • Female participants who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether collagenase injection is as good as surgery (limited fasciectomy) in the correction of Dupuytren’s contracture of the hand;Secondary Objective: To investigate the cost-effectiveness of collagenase injections compared to surgery (limited fasciectomy) 2 years after treatment. To investigate whether the correction achieved after collagenase injection or surgery is maintained to 5 years (If justified by findings from the analysis at 1 year and 2 years) To explore patient’s experiences and preferences of the different treatments (Qualitative sub study). To investigate if remote measurement (using photographs) of finger extension is as good as goniometric measurements in clinic to determine recurrence (Photography sub study). ;Primary end point(s): The primary endpoint is change in Patient Evaluation Measure (PEM) between baseline and 1 year. PEM is a validated patient report questionnaire of 11 items in the Hand Health and three in the Overall Assessment Questionnaire (including a transition question). ;Timepoint(s) of evaluation of this end point: Baseline, 3 months, 6 months, 1 year and 2 years after the intervention is delivered | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Unité Patient Rated Outcome Measure (URAM): A validated, nine item, six interval disease specific disability scale. - Michigan Hand Questionnaire (MHQ): A validated, 63 question measure featuring six domains relating to hand function, daily living, pain and aesthetics. - EQ-5D-5L: A validated, generic health status measure accompanied by a health status thermometer visual analogue scale (VAS). - Resource Use: Patient reported - Further Procedures: Clinician and Patient reported - Complications: Clinician and Patient reported - Recurrence: Assessed by clinicians during follow up visits, using the primary definition - change in extension deficit of 6 degrees between 3 and 6 months, or 20 degrees from 3 months to 1 year post treatment. - Extension deficit and total active movement: Assessed by clinicians during follow up visits. - Time to recovery of function: The SANE question, "From 0 – 100%, where do you put yourself currently in regards to your prior level of function?" collected from participants using postcards.;Timepoint(s) of evaluation of this end point: Baseline, 3 months, 6 months, 1 year and 2 years after the intervention is delivered, with the exception of the SANE question which is also collected at 2 and 6 weeks. The Michigan Hand Question will only be collected on an annual basis after Baseline. | — |
Countries
United Kingdom
Contacts
Public ContactYork Trials Unit,
University of York
Outcome results
None listed