UMIN-CTR Clinical Trial

Public title

Clinical and radiographic outcomes in navigation and conventional total knee arthroplasty

Acronym

Clinical and radiographic outcomes in navigation and conventional total knee arthroplasty

Scientific Title

Clinical and radiographic outcomes in navigation and conventional total knee arthroplasty

Scientific Title:Acronym

Clinical and radiographic outcomes in navigation and conventional total knee arthroplasty

Region

Japan

Condition

Osteoarthritis, rheumatoid arthritis, osteonecrosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

(i) To investigate the prevalence of femoral / tibial bowing in patients with knee osteoarthritis; (ii) to assess the impact of femoral / tibial bowing on radiographic parameters; (iii) to compare the radiographic parameters between the navigation group and the conventional group.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(i) to assess the impact of femoral / tibial bowing on radiographic parameters; (ii) to compare the radiographic parameters between the navigation group and the conventional group.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Various radiographic parameters, including coronal / sagittal bowing, lower leg alignment, component position, and outliers are compared between the navigation group and the conventional group.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with osteoarthritis, osteonecrosis, and rheumatoid arthritis undergoing total knee arthroplaties.

Key exclusion criteria

no

Target sample size

100

Name of lead principal investigator

1st name	Hideo
Middle name
Last name	Kobayashi

Organization

Yokohama City University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

2360004

Address

3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

TEL

045-787-2655

Email

hi-deo@live.jp

Name of contact person

1st name	Hideo
Middle name
Last name	Kobayashi

Organization

Yokohama City University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

2360004

Address

3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

TEL

045-787-2655

Homepage URL

Email

hi-deo@live.jp

Institute

Yokohama City University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University School of Medicine

Address

3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

Tel

045-787-2800

Email

hi-deo@live.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

2017

Year

06

Month

13

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/28087396/

Publication of results

Partially published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/28087396/

Number of participants that the trial has enrolled

35

Results

Femoral bowing varied from -7.4 to 10.9 with an average of 3.0. Tibial bowing varied from -4.1 to 4.6 with an average of 0.4. The femoral component was placed more properly with less outlier in the navigation group. The outlier of the femoral component angle was lower in the non-bowing group than in the bowing group.

Results date posted

2023

Year

12

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Seventy simultaneous bilateral TKAs on 35 patients with knee osteoarthritis, Kellgren-Lawrence grade IV, were enrolled in this study. The patients included 3 men and 32 women aged 57 to 87. Preoperative data are provided in Table 1.

Participant flow

Seventy simultaneous bilateral TKAs on 35 patients with knee osteoarthritis, Kellgren-Lawrence grade IV, were enrolled in this study. The Institutional Review Board approved the study, and all patients provided informed consent to participate in it. The patients included 3 men and 32 women aged 57 to 87. Preoperative data are provided in Table 1.

Adverse events

None

Outcome measures

Preoperative coronal bowing were measured, and the subjects were divided into 2 subgroups, i.e. the bowing group and the non-bowing group. Lateral bowing was expressed as plus (+) and medial bowing was expressed as minus (-). Various radiographic parameters, including coronal bowing, lower leg alignment, component position, and outliers were compared between the navigation group and the conventional group.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

10

Month

01

Day

Date of IRB

2012

Year

10

Month

01

Day

Anticipated trial start date

2012

Year

10

Month

01

Day

Last follow-up date

2020

Year

06

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

13

Day

Last modified on

2023

Year

12

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031779