UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049945 |
|---|---|
| Receipt number | R000056885 |
| Scientific Title | Incidence Of Osteoarthritis After Anatomical Anterior Cruciate Ligament Reconstruction |
| Date of disclosure of the study information | 2023/06/15 |
| Last modified on | 2022/12/30 21:54:35 |
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Basic information
Public title
Incidence Of Osteoarthritis After Anatomical Anterior Cruciate Ligament Reconstruction
Acronym
Osteoarthritis After Anatomical Anterior Cruciate Ligament Reconstruction
Scientific Title
Incidence Of Osteoarthritis After Anatomical Anterior Cruciate Ligament Reconstruction
Scientific Title:Acronym
osteoarthritis After Anatomical Anterior Cruciate Ligament Reconstruction
Region
| Asia(except Japan) |
Condition
Condition
continue
Classification by specialty
| Surgery in general | Orthopedics | Operative medicine |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of our study was to evaluate the presence of osteoarthritis in the long-term outcomes of patients treated for anterior cruciate ligament (ACL) tear with anatomical reconstruction.
Our secondary aim is to evaluate whether there is a difference in the development of knee osteoarthritis between patients with anatomical ACL reconstruction and patients with non-anatomical ACL surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence Of Osteoarthritis
Key secondary outcomes
isokinetic muscle strength, functionality, pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
anatomic acl reconstruction
Interventions/Control_2
non-anatomic acl reconstruction
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Having undergone isolated anatomical anterior cruciate ligament reconstruction,
At least 10 years have passed since anatomic and non-anatomical ACL reconstruction surgeries,
the time elapsed from injury to surgery should not exceed 6 months,
Willingness to participate in the study,
No revision surgery,
The age range is between 18 and 64.
Key exclusion criteria
Having additional injuries such as meniscus, cartilage, posterior cruciate ligament, lateral collateral ligament, posterolateral corner injury accompanying the ACL injury,
Those with previous lower extremity pathology,
Those with chronic comorbidities,
those undergoing hormone replacement therapy,
Those who use drugs that affect bone turnover.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hayri |
| Middle name | Baran |
| Last name | Yosmaoglu |
Organization
Baskent University
Division name
physiotherapy and rehabilitation
Zip code
06790
Address
basket university, heakth science faculty, physiotherapy and rehabilitation
TEL
03122466666
baran79@gmail.com
Public contact
Name of contact person
| 1st name | Hayri |
| Middle name | Baran |
| Last name | Yosmaoglu |
Organization
Baskent Univesity
Division name
physiotherapy and rehabilitation
Zip code
06790
Address
basket university, heakth science faculty, physiotherapy and rehabilitation
TEL
03122466666
Homepage URL
baran79@gmail.com
Sponsor or person
Institute
Baskent University
Institute
Department
Personal name
Funding Source
Organization
Baskent University
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
Baskent University
Address
basket university, heakth science faculty, physiotherapy and rehabilitation
Tel
03122466666
baran79@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
| 2023 | Year | 06 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 30 | Day |
Last modified on
| 2022 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056885
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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