UMIN-ICDS Clinical Trial

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

Knee osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Error from preoperative prediction of medial proximal tibial angle on radiographs 1 month after surgery

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

h.takuwa@med.shimane-u.ac.jp

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

Email

h.takuwa@med.shimane-u.ac.jp

Institute

Shimane University

Institute

Department

Personal name

Organization

Shimane University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee, Shimane University Faculty of Medicine

Address

89-1 Enya-cho, Izumo, Shimane Prefecture, Japan

Tel

0853-20-2515

Email

kenkyu@med.shimane-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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%.

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/icdr_e/ctr_view.cgi?recptno=R000056880