UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041958 |
|---|---|
| Receipt number | R000047890 |
| Scientific Title | A new method for the treatment of intractable bony ankylosis of the temporomandibular joint utilizing intentional pseudoarthrosis |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/30 19:31:33 |
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Basic information
Public title
A new method for the treatment of intractable bony ankylosis of the temporomandibular joint utilizing intentional pseudoarthrosis
Acronym
A new method for the treatment of bony ankylosis of the temporomandibular joint
Scientific Title
A new method for the treatment of intractable bony ankylosis of the temporomandibular joint utilizing intentional pseudoarthrosis
Scientific Title:Acronym
A new method for the treatment of bony ankylosis of the temporomandibular joint
Region
| Japan |
Condition
Condition
bony ankylosis of the temporomandibular joint
Classification by specialty
| Oral surgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are two major treatment options for bony ankylosis. One treatment is to use artificial joint, and another is to use interpositional graft. However, most cases recognized early recurrence a few months after arthroplasty and resulted in unsatisfactory results. Under these circumstances, we develop new method for these intractable bony ankylosis, named intentional pseudoarthrosis method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of opening mouth 1 year after operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Osteotomy of temporomandibular joint and attachment of internal distraction device
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
| 15 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Bony ankylosis of temporomandibular joint
Key exclusion criteria
Patients with multiple organ failure
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Mine |
| Middle name | |
| Last name | Ozaki |
Organization
Kyorin University School of Medicine
Division name
Department of Plastic Surgery
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
zakimin@nifty.com
Public contact
Name of contact person
| 1st name | Mine |
| Middle name | |
| Last name | Ozaki |
Organization
Kyorin University School of Medicine
Division name
Department of Plastic Surgery
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
zakimin@nifty.com
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No need
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public fund managemant, kyorin University
Address
6-20-2, Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
kenkyushien@ks.kyorin-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
| 2020 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047890
