UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045922 |
|---|---|
| Receipt number | R000052415 |
| Scientific Title | Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2024/05/13 20:37:15 |
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Basic information
Public title
Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction
Acronym
Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction
Scientific Title
Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction
Scientific Title:Acronym
Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the recovery process of the reconstructed ligament in patients with anterior cruciate ligament injury in combination with hyperbaric oxygen therapy using longitudinal MRI images. In addition, quantitative evaluation of vascular endothelium formation promoting cells among bone marrow derived stem/progenitor cells expressed in postoperative peripheral blood will be performed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of maturation of the anterior cruciate ligament by MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hyperbaric oxygen therapy
Interventions/Control_2
Standard treatment
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
| 14 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 14 to 45 at the time of consent
2) Patients with traumatic anterior cruciat
e ligament injury (whether fresh or old)
3) Patients with consent from the substitute
Key exclusion criteria
1) Patients with inflammatory disease
2) Patients with intra-articular fracture and osteochondral injury
3) Patients on bone metabolism regulating drugs
4) Patients who have received hyperbaric oxygen therapy within one month prior to informed consent
5) Patients with compound ligament injury who require surgical treatment for ligament injuries other than the anterior cruciate ligament
6) Patients with a history of surgical treatment on the affected knee
7)Patients with physical reasons or mental disorders that prevent MRI
8) Chronic lung disease, chronic sinusitis, nasal polyps, upper respiratory tract inflammation and other sinus stenosis have been pointed out, pneumothorax history, other otolaryngological diseases, etc.
9) When it is judged that HBO continuation is not preferable due to the exacerbation of the underlying disease
10) Patients found to be pregnant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Enokida |
Organization
Tottori University Hospital
Division name
Division of Orthopedic Surgery
Zip code
6838504
Address
36-1 Nishi-machi, Yonago-shi, Tottori-ken
TEL
0859386587
enokida@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Enokida |
Organization
Tottori University Hospital
Division name
Division of Orthopedic Surgery
Zip code
6838504
Address
36 -1 Nishi-machi, Yonago-shi, Tottori-ken
TEL
0859386587
Homepage URL
enokida@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
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
Tottori University Ethical Review Board
Address
36-1 Nishi-machi, Yonago-shi, Tottori-ken
Tel
0859387015
crsc@ml.med.tottori-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
| 2021 | Year | 10 | Month | 29 | 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
34
Results
mage analysis in progress.
Results date posted
| 2024 | Year | 05 | Month | 13 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Time-consuming image analysis.
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
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052415
