UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022186 |
|---|---|
| Receipt number | R000025536 |
| Scientific Title | Clinical outcome for a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor. |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2023/11/08 11:59:37 |
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Basic information
Public title
Clinical outcome for a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Acronym
Clinical outcome of a novel unidirectional porous tricalcium phosphate
Scientific Title
Clinical outcome for a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Scientific Title:Acronym
Clinical outcome of a novel unidirectional porous tricalcium phosphate
Region
| Japan |
Condition
Condition
benign bone tumor or bone disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical outcome of a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiograhic evaluation at 4weeks, 8weeks, 3monts, 6months, 9months, 12months after surgery)
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
| Device,equipment |
Interventions/Control_1
1.Application of this material to bone defect after bone resection.
2.CT 3 times, laboratory examination 3 times
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
1.Patients who diagnosed as benign bone tumor
2.Patients who applied this material to bone defect after bone resection.
3.Patients who gave written informed consent
Key exclusion criteria
Patients who do not consent to this study.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya University Hospital
Division name
Department of Rehabilitation
Zip code
4668550
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi
TEL
052-744-1908
ynishida@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Ikuta |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
4668550
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi
TEL
052-744-1908
Homepage URL
k-ikuta@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kuraray
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
iga-sou1@adm.med.nagoya-u.ac.jp
Address
IRB of Nagoya University Hospital
Tel
0527412111
iga-sou1@adm.med.nagoya-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
| 2016 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/detail/jr?trial_id=jRCTs041180171
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-022-20359-5
Number of participants that the trial has enrolled
68
Results
The present study showed the usefulness of low-porous beta-TCP with a unidirectional porous structure for filling the defects after surgery for benign bone lesions. A combination of evaluation with radiographs and bone metabolism markers at an early stage postoperatively may help clinicians predict the clinical course of patients. Our results need to be confirmed in larger sample sizes and longer follow-up periods.
Results date posted
| 2023 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 26 | Day |
Baseline Characteristics
Cohort1: Age Median 17 years, Male 29 cases, Female 15 cases
The diagnoses were as follows: non ossifying fibroma 7 cases, osteoid ostoma 6 cases, simple bone cyst 4 cases, giant cell tumor of bone 2 cases.
The locations were as follows: tibia 16 cases, femur 10 cases, humerus 4 cases, radius 3 cases.
Cohort2: Age Median 39 years, Male 11 cases, Female 19 cases
The common diagnosis was enchondroma, 28 cases. The locations were phalanges of hands and metacarpal bones, 24 cases and phalanges of toes 6 cases.
Participant flow
(Plan) Cohort1: 30 cases, Cohort2: 30 cases
(Enrollment) Cohort1: 44 cases, Cohort2: 30 cases
(Analysis) Cohort1: 30 cases, Cohort2: 26 cases
Adverse events
No adverse events occurred with the use of Affinos. Although two patients discontinued this study due to recurrence, these were oncologic events and not related to Affinos.
Outcome measures
The results in cohort 1 are as follows.
The values of resorption and trabeculation 12 months after surgery were 82.5% (range, 25-100) and 94.2% (range, 25-100). The location of the diaphysis, smaller defect volume, and the increased values of resorption 3 months postoperatively were associated with the increased value of resorption 12 months after surgery. The variable associated with the values of trabeculation 12 months after surgery was the trabeculation value 2 months after surgery.
The results in cohort 2 are as follows.
The values of resorption and trabeculation 12 months after surgery were 89.0% (range, 75-100) and 98.1% (range, 75-100). The increased values of resorption 2 months after surgery and smaller defect volume significantly correlated with the increased values of resorption 12 months after surgery.
No significant differences were detected in the values of resorption or trabeculation between plain radiographs and CT images 3 months after surgery. At 9 months after surgery, the values of trabeculation were significantly lower in CT than in plain radiographic evaluation. There was no significant difference in the values of resorption between plain radiographs and CT images 9 months after surgery.
There was a negative correlation between the ratio of 1CTP 3 months after surgery and the values of trabeculation 12 months after surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025536
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/11/19 | 研究計画書20210201.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
