UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029826 |
|---|---|
| Receipt number | 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 | 2023/11/10 09:17:06 |
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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
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
michi-ya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
https://assets.researchsquare.com/files/rs-651200/v1/26a0ee1c-295d-44f0-bee6-e8dd7e7ca90c.pdf?c=1631
Publication of results
Partially published
Result
URL related to results and publications
https://assets.researchsquare.com/files/rs-651200/v1/26a0ee1c-295d-44f0-bee6-e8dd7e7ca90c.pdf?c=1631
Number of participants that the trial has enrolled
78
Results
Participants comprised 52 patients in the Collagenase group and 26 patients in the Surgery group.
Hand10 score was significantly better in the Collagenase group at 1 and 2 weeks. EQ-5D-5L score was
significantly higher in the Collagenase group at 8 weeks. Mean direct cost was 248,000 yen higher in the
Surgery group than in the Collagenase group.
Results date posted
| 2021 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were: 1) patients with passive extension deficit in either only PIP joints or both PIP
and MP joints; 2) flexion contractures in at least two fingers of one hand
Participant flow
A total of 98 participants were initially enrolled in this study from April 2018 to July 2019. Of those, 20 were excluded, and data from 52 patients in the Collagenase group and 26 patients in the Surgery group (total cohort, 78 patients) were analyzed.
Adverse events
Recurrences were more frequent in the Collagenase group than in the Surgery group (18% vs 9.5%).
All complications in both groups were minor without additional surgery or anesthesia.
Outcome measures
Hand10, EQ-5D, ROM
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
We will start this study from January 2018.
we have analyzed 26 week data.
Management information
Registered date
| 2017 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033666
