UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049941 |
|---|---|
| Receipt number | R000056880 |
| Scientific Title | Benefits of preoperative digital planning for high tibial osteotomy of the knee |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 19:25:44 |
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Basic information
Public title
Benefits of preoperative digital planning for high tibial osteotomy of the knee
Acronym
Benefits of preoperative digital planning for high tibial osteotomy of the knee
Scientific Title
Benefits of preoperative digital planning for high tibial osteotomy of the knee
Scientific Title:Acronym
Benefits of preoperative digital planning for high tibial osteotomy of the knee
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of preoperative planning using digital planning software in opening-wedge high tibial osteotomy for knee osteoarthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Error from preoperative prediction of medial proximal tibial angle on radiographs 1 month after surgery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with primary knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) of the medial femoro-tibial joint only.
2) Between January 2021 and December 2022, wedge-shaped open high tibial osteotomy was performed at our hospital.
3) Age at the time of surgery is 50 to 75 years old.
4) The range of motion of the joint is -10 degrees or less in extension and 120 degrees or more in flexion.
Key exclusion criteria
1) Complicated with knee ligament insufficiency.
2) Complications of connective tissue disease.
3) Complicated arthritis.
4) Smokers.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takuwa |
Organization
Shimane University
Division name
Department of Orthopaedic Surgery
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane Prefecture, Japan
TEL
+81-853-20-2240
h.takuwa@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takuwa |
Organization
Shimane University
Division name
Department of Orthopaedic Surgery
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane Prefecture, Japan
TEL
0853202242
Homepage URL
h.takuwa@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane 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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane Prefecture, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2022 | Year | 12 | Month | 28 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 30 | 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
This study is a single-institution retrospective observational study. The subjects were patients who underwent open wedge high tibial osteotomy at our hospital from January 2021 to December 2022. They are divided into the following two groups according to the method of preoperative planning. 20 consecutive cases until December 2021 were manually drawn on an electronic medical record by the operator in the 'conventional group (C group)', and 20 consecutive cases after March 2022 were drawn using digital planning software (mediCAD, Toyo Technica, Tokyo) is used as a 'digital group (D group)'. In group D, the preoperative image data is imported into a dedicated PC with software installed and plotted. Using the preoperative full-length lower limb X-ray image, the target alignment for surgery is set so that the functional axis of the lower limb passes through the Fujisawa point (% mechanical axis (%MA) = 62.5%). (1) opening angle, (2) opening distance, (3) medial proximal tibial angle (MPTA), and (4) %MA were measured from the preoperative planning image and the X-ray image one month after surgery. value - postoperative measurement value) (Fig. 3). Compare the errors in groups C and D between the two groups. Statistically, the Mann-Whitney's U test is used, and a significant difference is determined when the risk rate is less than 5%.
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056880
