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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name