UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062546 |
|---|---|
| Receipt number | R000071592 |
| Scientific Title | Examination of the Patient Acceptable Symptom State (PASS) for the Patient-Rated Wrist Evaluation (PRWE) in Patients After Distal Radius Fracture Surgery |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/08/12 09:08:26 |
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Basic information
Public title
Examination of the Patient Acceptable Symptom State (PASS) for the Patient-Rated Wrist Evaluation (PRWE) in Patients After Distal Radius Fracture Surgery
Acronym
Examination of the Patient Acceptable Symptom State (PASS) for the Patient-Rated Wrist Evaluation (PRWE) in Patients After Distal Radius Fracture Surgery
Scientific Title
Examination of the Patient Acceptable Symptom State (PASS) for the Patient-Rated Wrist Evaluation (PRWE) in Patients After Distal Radius Fracture Surgery
Scientific Title:Acronym
Examination of PRWE PASS in Patients After Surgery for Distal Radius Fractures
Region
| Japan |
Condition
Condition
Distal Radius Fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish the PASS threshold for the PRWE in patients who underwent surgical treatment for distal radius fractures.
Basic objectives2
Others
Basic objectives -Others
Validation of efficacy indicators
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PASS Anchor Question
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with a distal radius fracture
Patients who underwent open reduction and internal fixation (ORIF)
Patients aged 18 years or older
Patients capable of completing the questionnaire in Japanese
Patients who provided verbal consent
Key exclusion criteria
Bilateral distal radius fractures
Complex tissue injury (complicated by vascular or nerve injury)
Pathological fractures other than osteoporotic fractures
Severe cognitive impairment
Inability to complete the questionnaire due to comorbid psychiatric disorders
Patients who do not consent to participate in the study
Patients unable to complete the questionnaire in Japanese
Patients with a history of trauma or surgery on the ipsilateral wrist that affects function
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Rehabilitation
Zip code
3908510
Address
2-5-1 Honjo, Matsumoto City, Nagano Prefecture, Japan
TEL
81-0263-33-8600
ai.47324@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Rehabilitation
Zip code
3908510
Address
2-5-1 Honjo, Matsumoto City, Nagano Prefecture, Japan
TEL
81-0263-33-8600
Homepage URL
ai.47324@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aizawa Hospital Clinical Research Ethics Committee
Address
2-5-1 Honjo, Matsumoto City, Nagano Prefecture, Japan
Tel
81-0263-33-8600
kenkuy@hosp.or.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
| 2026 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study aimed at establishing the PASS [Patient Acceptable Symptom State] threshold for the PRWE [PatientRated Wrist Evaluation]. The study targets patients undergoing open reduction and internal fixation for distal radius fractures in an orthopedic setting who meet the specified selection criteria. While the MCID [Minimal Clinically Important Difference] for the PRWE indicating the magnitude of improvement has already been determined [11.5-14 points], the threshold for PASS representing the absolute level at which patients consider their condition acceptable has not yet been established. The objective of this study is to establish the PRWE PASS threshold for patients who have undergone surgical treatment, assessed at 6 weeks, 3 months, and 6 months postoperatively.
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071592
