UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004220
Receipt number R000005072
Scientific Title Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology
Date of disclosure of the study information 2010/09/16
Last modified on 2014/10/21 14:09:45

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Basic information

Public title

Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology

Acronym

Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology

Scientific Title

Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology

Scientific Title:Acronym

Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology

Region

Japan


Condition

Condition

Patients who have been diagnosed secondary hip osteoarthritis with acetabular dysplasia (Crowe classification; type I to IV)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the consistency of stem component/neck component of the M/L Taper Kinectiv Stem selected through preoperative 3D-templating and the device actually implanted and the clinical outcomes including X-ray evaluation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To investigate the consistency of stem component/neck component of the M/L Taper Kinectiv Stem selected through preoperative 3D-templating and the device actually implanted

Key secondary outcomes

To investigate clinical outcomes(JOA score, Harris Hip Score, SF-12 and X-ray) for 24-month postoperatively


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology by THA

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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Age: 20 to 75 years
2)Sex: Both males and females
3)A patient with ability to consent who can sign the informed consent form by themselves
4)A patient who are expected to cooperate with this study throughout the study period

Key exclusion criteria

1)A patient who underwent artificial joint replacement or osteotomy of the affected lower limb
2)A patient with infection-like symptoms such as osteomyelitis of the proximal femur and suppurative infection of the hip joint.
3)A patient with neuromuscular disorder (Charcot's joint, etc.) in the affected limb
4)A patient who are skeletally immature
5)A patient with loss or atrophy of the abductor muscle in the affected limb
6)A patient with insufficient bone mass (due to steroid-induced metabolic bone disorder, etc.)
7)A patient with insufficient skin coverage around the hip joint
8)A patient with local or systemic infection
9)A patient with the stove-pipe femur
10)A patients with suspected metal allergies
11)Other patients who are determined to be ineligible for total hip arthroplasty and this study by the investigator

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Hirakawa

Organization

Shonan Kamakura Joint Reconstruction Center

Division name

Department of Orthopaedic Surgery

Zip code


Address

4-17, 5-chome, Dai, Kamakura-shi, Kanagawa prefecture, Japan

TEL

0467-47-2377

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Tsuji

Organization

Shonan Kamakura Joint Reconstruction Center

Division name

Department of Orthopaedic Surgery

Zip code


Address

4-17, 5-chome, Dai, Kamakura-shi, Kanagawa prefecture, Japan

TEL

0467-47-2377

Homepage URL


Email

koji502@mac.com


Sponsor or person

Institute

Shonan Kamakura Joint Reconstruction Center

Institute

Department

Personal name



Funding Source

Organization

Zimmer Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

U.S.


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

医療法人 沖縄徳洲会 湘南鎌倉人工関節センター(神奈川県)/ Shonan Kamakura Joint Reconstruction Center(kanagawa)


Other administrative information

Date of disclosure of the study information

2010 Year 09 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

Completed

Date of protocol fixation

2010 Year 05 Month 06 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2013 Year 07 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 16 Day

Last modified on

2014 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005072


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name