UMIN-CTR Clinical Trial

Public title

Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases

Acronym

Clinical study of a new prosthesis for total hip arthroplasty (AMU001)

Scientific Title

Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases

Scientific Title:Acronym

Clinical study of a new prosthesis for total hip arthroplasty (AMU001)

Region

Japan

Condition

Osteoarthritis of the Hip, Osteo necrosis of the Femoral Head, Rheumatoid arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This clinical trial is conducted for the patients with hip joint diseases. The efficiency and safety of the test device, a new prosthesis for total hip arthroplasty(AMU001), will be evaluated 12 months after surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

JOA Score

Key secondary outcomes

Efficiency:
Radiographic assessment
Safety:
Adverse events
Radiographic assessment

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

Device,equipment

Interventions/Control_1

Implantation of a hip prosthesis

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Inclusion criteria:
1) Osteoarthritis of the hip:
advanced or end stage
2) Osteonecrosis of the Femoral Head: Stage 3A, 3B, or 4
3) Rheumatoid arthritis:
Larsen Grade2 or greater than grade 2
(2) JOAscore<=69
(3) Patient's agreement
(4) Age>=20

Key exclusion criteria

(1) Patient had previously received hip prosthesis in the same hip joint.
(2) Patient received artificial joint prosthesis in lower extremity within 180 days.
(3) In the other side of the hip;
1) loosening of total hip arthroplasty or hemiarthroplasty
2) osteotomy or soft tissue release around hip joint is scheduled within one year

(4) Charnley category C
(5) Body weight>=80kg, BMI>=30
(6) Severe osteoporosis
(7) Abscess or infection around hip joint
(8) Metal allergy
(9) It is difficult to follow the hip precautions due to neurological disorder, mental illness, alcohol dependence, or drug abuse.
(10) joined other clinical trial within 90 days
(11) in pregnancy or scheduled to become pregnant during this clinical trial.
(12) it is not possible to stop to use anticoagulant or antiplatelet drug from one week before surgery.
(13) Patient who is determined to be excluded from the clinical trial due to any reasons by the study doctor.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	(1) Hiroshi Ito (2) Takeshi Masuda

Organization

(1) Asahikawa Medical University Hospital
(2) Eniwa Hospital

Division name

(1) Orthopaedics (2) Orthopaedics

Zip code

Address

(1) Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan (2) 2-1-1, Koganechuou, Eniwa, Hokkaido, Japan

TEL

0166-68-2511

Email

itohiro@asahikawa-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Masaaki Kato

Organization

National University Corporation Asahikawa Medical University

Division name

General Affairs Division

Zip code

Address

Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan

TEL

0166-68-2189

Homepage URL

Email

sho-kenkyu@jimu.asahikawa-med.ac.jp

Institute

Asahikawa Medical University Hospital Orthopaedics

Institute

Department

Personal name

Organization

Asahikawa Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Center for Translational Research, Hokkaido University
NAKASHIMA MEDICAL CO, LTD.

Name of secondary funder(s)

NAKASHIMA MEDICAL CO, LTD.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

①国立大学法人旭川医科大学病院 （北海道）
②医療法人社団我汝会えにわ病院（北海道）

Date of disclosure of the study information

2011

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

08

Month

30

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

2014

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

08

Month

24

Day

Last modified on

2014

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007355