UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052334 |
|---|---|
| Receipt number | R000059616 |
| Scientific Title | Anatomical Reconstruction Using Double-Bundle Substitutes in Double Tunnels of the Lateral Malleolus for Chronic Lateral Ankle Ligament Injuries |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/09/28 13:56:56 |
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Basic information
Public title
Anatomical ligament reconstruction for lateral ankle instability
Acronym
Anatomical lateral ankle ligament reconstruction
Scientific Title
Anatomical Reconstruction Using Double-Bundle Substitutes in Double Tunnels of the Lateral Malleolus for Chronic Lateral Ankle Ligament Injuries
Scientific Title:Acronym
Anatomical lateral ankle ligament reconstruction
Region
| Japan |
Condition
Condition
Instability of chronic lateral ankle ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anatomical ligament reconstruction for chronic lateral ankle ligament injuries
Basic objectives2
Others
Basic objectives -Others
To compare the stability and function of three different fixation methods of the substitute ligament in anatomical graft placement.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
"Pain," "gait function," "mobility," "stability," and "alignment" from the "Japanese Society of Foot Surgery's Rearfoot Function Evaluation Scale" are measured for clinical function evaluation, "pain," "physical function," "social function," "shoes," and "overall sense of health" from "Safe-Q" for patient-oriented evaluation, and "talar tilt angle," "Anterior Drawer %," and "joint dissection distance" from stress radiographs for the radiologic assessment before surgery and one year after surgery.
Key secondary outcomes
Postoperative re-injury and instability recurrence rates
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Two substitute ligaments from the looped gracilis tendon will be grafted between the anatomical origin and insertion of the anterior talofibular and calcaneofibular ligament.
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
| 14 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ankle instability, history of multiple ankle ligament injuries, residual ligaments of insufficient strength
Key exclusion criteria
Complications of osteochondral fractures of the talus
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | ozeki |
Organization
Showa University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
142-0064
Address
1 Chome-5-8 Hatanodai, Shinagawa City, Tokyo
TEL
090-4173-9546
ozeks55@gmail.com
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Ozeki |
Organization
Laketown Orthopaedic Hospital
Division name
International Foot and Ankle center
Zip code
343-0828
Address
5 Chome-13-6 Lake Town, Koshigaya, Saitama
TEL
0489872277
Homepage URL
ozeks55@gmail.com
Sponsor or person
Institute
Satoru Ozeki, MD
International Foot and Ankle Research Center
Laketown Orthopaedic Hospital
Institute
Department
Personal name
Satoru Ozeki
Funding Source
Organization
Satoru Ozeki, MD
International Foot and Ankle Research Center
Laketown Orthopaedic 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
Dokkyo Medical University Saitama Medical Center
Address
2 Chome-1-50 Minamikoshigaya, Koshigaya, Saitama 343-0845
Tel
0489651111
k1prof@me.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
獨協医科大学 埼玉医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | 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
165
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
Completed
Date of protocol fixation
| 1993 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 1993 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059616
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/10/11 | 2093 Application English.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/10/11 | SafeQ form.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/10/12 | Safe-Q results.xlsx |
