UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050443 |
|---|---|
| Receipt number | R000057452 |
| Scientific Title | A Randomized Control Trial of the Outcomes of Two Types of Bone Tunnel Creation Techniques in Anterior Cruciate Ligament Reconstruction of the Knee. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/02/28 08:41:43 |
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Basic information
Public title
A Randomized Control Trial of the Outcomes of Two Types of Bone Tunnel Creation Techniques in Anterior Cruciate Ligament Reconstruction of the Knee.
Acronym
Comparison of Outcomes by Bone Tunnel in ACL Reconstruction
Scientific Title
A Randomized Control Trial of the Outcomes of Two Types of Bone Tunnel Creation Techniques in Anterior Cruciate Ligament Reconstruction of the Knee.
Scientific Title:Acronym
Comparison of Outcomes by Bone Tunnel in ACL Reconstruction
Region
| Japan |
Condition
Condition
Anterior Cruciate Ligament Injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of Clinical Outcomes between two types of surgical technique in Anterior Cruciate Ligament Reconstruction.
Basic objectives2
Others
Basic objectives -Others
Comparison of clinical outcomes between existing two types of surgical techniques.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical evaluation, radiological findings, and Questionnaire assessment at pre- and postoperative 12, 24 months.
Key secondary outcomes
muscle strength test, CT, and MRI
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single-tunnel and single-bundle technique of ACL reconstruction. 24 months follow-up.
Interventions/Control_2
Double-tunnel and double-bundle technique of ACL reconstruction. 24 months follow-up.
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
Patients who are planning to undergo ACL reconstruction using the hamstrings tendon.
Key exclusion criteria
1. Revision surgery
2. History of injuries of the same knee
3. History of injuries in the contralateral knee
4. Concomitant ligament injuries of the knee
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideya |
| Middle name | |
| Last name | Yoshimura |
Organization
Kawaguchi Kogyo General Hospital
Division name
Department of Orthopaedic Surgery
Zip code
332-0031
Address
Aoki 1-18-15, Kawaguchi, Saitama, Japan
TEL
+810482524873
yyoshimura@cap.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hideya |
| Middle name | |
| Last name | Yoshimura |
Organization
Kawaguchi Kogyo General Hospital
Division name
Department of Orthopaedic Surgery
Zip code
332-0031
Address
Aoki 1-18-15, Kawaguchi, Saitama, Japan
TEL
+810482524873
Homepage URL
yyoshimura@cap.ocn.ne.jp
Sponsor or person
Institute
kawaguchi Kogyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawaguchi Kogyo General 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
Kawaguchi Kogyo General Hospital
Address
Aoki 1-18-15, Kawaguchi, Saitama, Japan
Tel
+810482524873
s-higuchi@kogyohsp.gr.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
| 2023 | Year | 04 | Month | 01 | 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 | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
