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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029826
Receipt No. R000033666
Scientific Title A comparative study of upper limb function and cost effectiveness after collagenase injection and aponeurectomy for Dupuytren contracture
Date of disclosure of the study information 2017/12/31
Last modified on 2019/05/08

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Basic information
Public title A comparative study of upper limb function and cost effectiveness after collagenase injection and aponeurectomy for Dupuytren contracture
Acronym CeCORD-J study
Scientific Title A comparative study of upper limb function and cost effectiveness after collagenase injection and aponeurectomy for Dupuytren contracture
Scientific Title:Acronym CeCORD-J study
Region
Japan

Condition
Condition Dupuytren contracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Collagenase injection was approved for Dupuytran contracture in Japan in 2015. A new option has been added to diseases that have been considered effective only for surgical treatment. There are advantages and disadvantages in surgical treatment or collagenase injection, respectively, and few reports have prospectively compared and examined treatment outcome and cost effectiveness using patient-based evaluation.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dupuytran contractures with palpable contracture cord were divided into two groups that were treated with collagenase injection or surgery (fasciectomy). The upper limb function before and after treatment is examined using a patient-rated outcome measure Hand10 as a primarily outcome. A cost utility analysis using direct cost and EQ-5D utility value is performed as secondary outcome. We will compare the injection group and surgery group.


Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient living in Japan who got written consent from this clinical study
1) Patients whose age is over 20 years
2) Dupuytran contracture of PIP (and MP) joint with palpable cord. One hand has two or more flexion contractures with more of which is Meyerding classification grade 2.
Sex is not to be taken into question.
Key exclusion criteria 1) Patients who had treated Dupuytran contracture in the past and recurred
2) Patients with a history of hypersensitivity to components of injectable collagenase
3) Patients who may be pregnant or pregnant, patients wishing for pregnancy during this clinical study or patients who may be pregnant, lactating patients
4) Patients who are receiving anticoagulant, antiplatelet drug (excluding aspirin at 150 mg / day or less) within 7 days before treatment
5) Patients who are separately participating in intervention tests such as trials and clinical trials
6) Patients who have difficulty understanding and answering inquiries of documents consent in Japanese,
7) Other Research Responsibilities (Sharing) Patients judged inappropriate for doctors to conduct this clinical study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Hirata
Organization Nagoya University
Division name Hand surgery
Zip code 466-8550
Address 65 Tsurumai-cho Showa-ku, Nagoya
TEL 052-744-2957
Email h-hirata@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Michiro
Middle name
Last name Yamamoto
Organization Nagoya University
Division name Hand surgery
Zip code 466-8550
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2957
Homepage URL
Email michi-ya@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Asahikasei Phama
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University
Address 65 Tsurumaicho, Showaku, nagoya
Tel 0527442423
Email iga-shinsa@adm.nagoya-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 11 Month 05 Day
Date of IRB
2018 Year 03 Month 05 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will start this study from January 2018.

Management information
Registered date
2017 Year 11 Month 05 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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