UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044979
Receipt number R000051392
Scientific Title Accuracy of AR navigation for cup placement in total hip arthroplasty
Date of disclosure of the study information 2021/08/16
Last modified on 2022/08/29 17:04:02

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Basic information

Public title

Accuracy of AR navigation for cup placement in total hip arthroplasty

Acronym

Accuracy of AR navigation for cup placement in total hip arthroplasty

Scientific Title

Accuracy of AR navigation for cup placement in total hip arthroplasty

Scientific Title:Acronym

Accuracy of AR navigation for cup placement in total hip arthroplasty

Region

Japan


Condition

Condition

Osteoarthritis, Osteonecrosis of femooral head,Rapidly destructive coxarthropathy,Rheumatoid arthritis, Femoral neck fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the accuracy of cup placement with AR navigation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cup position

Key secondary outcomes

Operative factors, Clinical score, Postoperative course


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Cup is positioned with AR navigation

Interventions/Control_2

Cup is positioned without navigation

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Osteoarthritis, Osteonecrosis of femoral head, Rapidly destractive coxarthropathy, Rheumatoid arthritis, Femoral neck fracture
2.20 years old or >20 years old
3.Willingness to participate
4.One side of hip joint, even if bilateral hip disease

Key exclusion criteria

1.Neurological disease, Difficult to follow phyician instructions
2.Osteomalacia, Severe osteoporosis
3.Metabolic disease affecting bone
4.Infection around hip joint
5.Severe bone defect
6.Not suitable for the clinical trial judged by physician

Target sample size

72


Research contact person

Name of lead principal investigator

1st name Hiromasa
Middle name
Last name Tanino

Organization

Asahikawa Medical University

Division name

Department of Orthopaedic Surgery

Zip code

078-8510

Address

Midorigaoka Higashi 2-1-1-1, Asahikawa

TEL

0166-68-2512

Email

tanino@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Hiromasa
Middle name
Last name Tanino

Organization

Asahikawa Medical University

Division name

Department of Orthopaedic Surgery

Zip code

078-8510

Address

Midorigaoka Higashi 2-1-1-1, Asahikawa

TEL

0166-68-2512

Homepage URL


Email

tanino@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

No funding

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

Asahikawa Medical University

Address

Midorigaoka Higashi 2-1-1-1, Asahikawa

Tel

0166-65-2111

Email

rs-kk.g@asahikawa-med.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

2021 Year 08 Month 16 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

No longer recruiting

Date of protocol fixation

2021 Year 07 Month 19 Day

Date of IRB

2021 Year 07 Month 21 Day

Anticipated trial start date

2021 Year 08 Month 27 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 28 Day

Last modified on

2022 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name