UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057456 |
|---|---|
| Receipt number | R000065650 |
| Scientific Title | Thermal Changes and Clinical Outcomes Following Distal Radius Fractures: A Study on Heat Production |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2026/04/19 03:36:08 |
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Basic information
Public title
Thermal Changes and Clinical Outcomes Following Distal Radius Fractures: A Study on Heat Production
Acronym
Thermal Changes and Clinical Outcomes Following Distal Radius Fractures: A Study on Heat Production
Scientific Title
Thermal Changes and Clinical Outcomes Following Distal Radius Fractures: A Study on Heat Production
Scientific Title:Acronym
Thermal Changes and Clinical Outcomes Following Distal Radius Fractures: A Study on Heat Production
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bone fractures and surgical trauma induce inflammation that causes swelling, pain, and heat production. This prospective observational study investigated the relationship between heat production and clinical outcomes following surgical treatment of distal radius fractures (DRFs).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient-Rated Wrist Evaluation
Key secondary outcomes
Grip strength
Active ROM for wrist flexion/extension and forearm pronation/supination
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
Inclusion criteria were patients aged 18 or older, undergoing volar locking plate fixation for DRFs
Key exclusion criteria
Exclusion criteria were open fractures, pre-existing rheumatoid or collagen disorders, long-term steroid use, previous upper extremity fractures on either side, multiple traumas or fractures, and cognitive impairment.
Target sample size
99
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
390-8510
Address
Honjo 1-5-2, Matsumoto
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
390-8510
Address
Honjo 1-5-2, Matsumoto
TEL
81-0263-33-8600
Homepage URL
ai.47324@ai-hosp.or.jp
Sponsor or person
Institute
Department of Orthopaedic Rehabilitation, Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Aizawa Hospital Clinical Research Ethics Committee
Address
Honjo 1-5-2, Matsumoto 390-8510, 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
| 2025 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jht.2026.01.001
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jht.2026.01.001
Number of participants that the trial has enrolled
89
Results
The skin surface temperature difference was at its maximum on the day after surgery and significantly decreased at 6 weeks postoperatively. Univariate analysis revealed correlations between the skin surface temperature difference and grip strength at 3 weeks, as well as the wrist motion at 6 weeks. Multivariate analysis indicated that the skin surface temperature difference at 3 weeks predicted grip strength at 6 and 12 weeks.
Results date posted
| 2026 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 08 | Day |
Baseline Characteristics
The mean age was 65.8 (SD, 14.7) years; 67 (75%) were female, 34 (38%) had dominant-hand injuries, 21 (24%) suffered trauma from standing-height falls, 13 (15%) had associated ulnar fractures, and 70 (79%) had intra-articular fractures.
Participant flow
Participants were consecutively recruited from April 2022 to September 2023 until the required number was enrolled. Ninety-nine DRFs underwent surgery. Of these, 89 met the inclusion criteria and were enrolled; two open fractures and eight multiple fractures were excluded. No patients refused participation, and no patients were diagnosed with complex regional pain syndrome (CRPS) by the attending physician. One patient was lost to follow-up after participation.
Adverse events
none
Outcome measures
Heat production
Pain at rest
Pain during movement
Swelling (number of the ring gauge)
White blood cell
Creatine kinase
C-reactive protein
PRWE score
Grip strength
Range of motion Wrist flexion/extension Forearm pronation/supination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative therapy was not administered. The surgery was performed under regional anesthesia by an attending surgeon. No bone grafting or additional fixation with K-wires or small plates was done. When distal radioulnar joint instability was apparent, ulnar styloid fractures and/or triangular fibrocartilage complex tears were repaired using K-wires or bone anchors. No splint or orthosis was applied postoperatively. Patients were hospitalized on the day of surgery and discharged the next day with prescribed analgesics, though their use was not assessed. Follow-up visits were scheduled at 1, 3, 6, and 12 weeks postoperatively. Postoperative therapy was administered by an occupational therapist; however, its frequency and content were not standardized.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065650
