ISRCTN18254597已完成4 期
A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuytren’s contracture in adult patients
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 673 人开始时间: 2017年4月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 673
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34593024/ (added 19/10/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female and aged 18 years or over
- •2. Presence of discrete, palpable, contracted cord involving the metacarpophalangeal joint and/or proximal interphalangeal joint of a finger
- •3. Degree of contracture =30 degrees in either joint i.e. patient cannot put the palm of the hand flat on a table (Hueston’s Table top test)
- •4. Able to identify a predominant cord for treatment which would not require more than one Collagenase injection as treatment
- •5. Appropriate for limited fasciectomy surgery and Collagenase injection for Dupuytren’s contracture (i.e. cords suitable for CCH and limited fasciectomy and not requiring skin grafting or PNF (e.g. discrete MCP cords in elderly))
- •6. Patient is willing and able to give informed consent for participation in the study
排除标准
- •Current exclusion criteria as of 31/10/2018:
- •1. Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4)
- •2. History of previous intervention for Dupuytren’s contracture (e.g. surgery, Collagenase injection or needle fasciectomy) to the study reference digit
- •3. History of any other pre-existing disorder of the hand causing significant restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis
- •4. Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages
- •5. Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible
- •6. Contraindicated for use of Collagenase including hypersensitivity to: Collagenase, Sucrose, Ketorolac Trometamol, hydrochloric acid, calcium chloride dehydrate, sodium chloride
- •7. Diagnosis of a coagulation disorder
- •8. 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
- •9. Participation in another research study involving an investigational product in the past 12 weeks
- •10. Female participants who report to be pregnant or breastfeeding
- •Previous exclusion criteria:
- •1. Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4)
- •2. History of previous intervention for Dupuytren’s contracture (e.g. surgery, Collagenase injection or needle fasciectomy) on the same hand
- •3. History of any other pre-existing disorder of the hand causing significant restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis
- •4. Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages
- •5. Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible
- •6. Contraindicated for use of Collagenase including hypersensitivity to: Collagenase, Sucrose, Ketorolac Trometamol, hydrochloric acid, calcium chloride dehydrate, sodium chloride
- •7. Diagnosis of a coagulation disorder
- •8. 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
- •9. Participation in another research study involving an investigational product in the past 12 weeks
- •10. Female participants who report to be pregnant or breastfeeding
研究者
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