UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052323 |
|---|---|
| Receipt number | R000059732 |
| Scientific Title | Treatment selection and characteristics of patients with Preisers disease |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2023/09/27 13:22:03 |
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Basic information
Public title
Treatment selection and characteristics of patients with Preisers disease
Acronym
Treatment selection and characteristics of patients with Preisers disease
Scientific Title
Treatment selection and characteristics of patients with Preisers disease
Scientific Title:Acronym
Treatment selection and characteristics of patients with Preisers disease
Region
| Japan |
Condition
Condition
Preisers disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preisers disease is difficult to diagnose and treat due to its unclear pathophysiology. Although both nonsurgical and surgical treatment for Preisers disease have been reported, there is no consensus on the optimal treatment because of its rarity. The purpose of this study was to investigate the relationship between treatment selection and characteristics of patients with Preisers disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This single-institution retrospective chart review included 9 patients (2 male, 7 female) with Preisers disease who were treated at our hospital. We divided patients into 2 groups consisting of elderly (over 65 years of age) and non-elderly patients. Herbert-Lanzetta classification, presence of dorsal intercalated segment instability (DISI), Watson classification based on plain radiography, Kalainov classification based on magnetic resonance imaging (MRI), and treatment modalities were investigated in both groups.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This single-institution retrospective chart review extracted patient demographic characteristics, medical history, imaging findings, and follow-up data from medical records between July 2012 to July 2022. Patients who had radiographically confirmed vascular impairment of the scaphoid and underwent a treatment plan at our institution were included in this study.
Key exclusion criteria
We excluded patients who had a vascular impairment of the scaphoid with acute fracture or fracture non-union and visited our institution after being treated at other hospitals.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Ishizaka |
Organization
Niigata Hand Surgery Foundation
Division name
orthopedics
Zip code
957-0117
Address
997 Suwayama Seiro, Kitakambara, Niigata
TEL
0254-27-0003
keisuke_ishizaka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Ishizaka |
Organization
Niigata Hand Surgery Foundation
Division name
orthopedics
Zip code
957-0117
Address
997 Suwayama Seiro, Kitakambara, Niigata
TEL
0254-27-0003
Homepage URL
keisuke_ishizaka@yahoo.co.jp
Sponsor or person
Institute
Niigata Hand Surgery Foundation
Institute
Department
Personal name
Funding Source
Organization
no
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
Niigata Hand Surgery Foundation
Address
997 Suwayama Seiro, Kitakambara, Niigata
Tel
0254-27-0003
keisuke_ishizaka@yahoo.co.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
| 2023 | Year | 09 | Month | 27 | 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
9
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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059732
