UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059085 |
|---|---|
| Receipt number | R000067576 |
| Scientific Title | Evaluation of the Effectiveness of Early Postoperative Orthotic Therapy for Elbow Fractures |
| Date of disclosure of the study information | 2025/09/13 |
| Last modified on | 2025/09/13 19:43:53 |
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Basic information
Public title
Evaluation of the Effectiveness of Early Postoperative Orthotic Therapy for Elbow Fractures
Acronym
Evaluation of the Effectiveness of Early Postoperative Orthotic Therapy for Elbow Fractures
Scientific Title
Evaluation of the Effectiveness of Early Postoperative Orthotic Therapy for Elbow Fractures
Scientific Title:Acronym
Evaluation of the Effectiveness of Early Postoperative Orthotic Therapy for Elbow Fractures
Region
| Japan |
Condition
Condition
Elbow fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the use of orthoses and the type of orthoses in the early postoperative period for patients with elbow fractures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
range of motion of the elbow joint
Key secondary outcomes
pain intensity
Disability of the Arm, Shoulder, and Hand(DASH-JSSH)
Patient-Rated Elbow Evaluation(PREE-J)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standard rehabilitation is performed from 2 to 6 weeks post-surgery.
Use the elbow extension orthosis only at night.
Interventions/Control_2
In addition to standard rehabilitation, using a dynamic elbow flexion orthosis from 2 to 6 weeks post-surgery (30 minutes, 3 times a day).
Use the elbow extension orthosis at night.
Interventions/Control_3
In addition to standard rehabilitation, using a static progressive orthosis from 2 to 6 weeks post-surgery (30 minutes, 3 times a day).
Use the elbow extension orthosis at night.
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
1)Adequate fracture and/or ligamentous stability for use of mobilizing orthosis as determined by the surgeon.
2)Patients who were able to continue rehabilitation up to 6 weeks postoperatively.
3)Patients capable of operating orthotic devices independently.
Key exclusion criteria
1)Active infections or wound-healing issues
2)Heterotopic ossifications
3)Any neurlogical conditions
4)Burns-related contractures
5)Total elbow replacement
6)Patients with cognitive impairments
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | JUN |
| Middle name | |
| Last name | UCHIYA |
Organization
Gifu Prefectural General Medical Center
Division name
Division of Rehabilitation
Zip code
5008717
Address
4-6-1 Noishiki, Gifu city, Gifu, JAPAN
TEL
0582461111
uchiya08@gmail.com
Public contact
Name of contact person
| 1st name | JUN |
| Middle name | |
| Last name | UCHIYA |
Organization
Gifu Prefectural General Medical Center
Division name
Division of Rehabilitation
Zip code
5008717
Address
4-6-1 Noishiki, Gifu city, Gifu, JAPAN
TEL
0582461111
Homepage URL
uchiya08@gmail.com
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Hand Therapy Society
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
Gifu Prefectural General Medical Center
Address
4-6-1 Noishiki, Gifu city, Gifu, JAPAN
Tel
0582461111
uchiya08@gmail.com
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
| 2025 | Year | 09 | Month | 13 | 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
| 2024 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067576
