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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004797
Receipt No. R000005710
Scientific Title Clinical Study on the Efficacy and Safety of Z101101 in Total Hip Arthroplasty
Date of disclosure of the study information 2011/01/14
Last modified on 2014/01/06

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Basic information
Public title Clinical Study on the Efficacy and Safety of Z101101 in Total Hip Arthroplasty
Acronym Clinical Study on the Efficacy and Safety of Z101101 in Total Hip Arthroplasty
Scientific Title Clinical Study on the Efficacy and Safety of Z101101 in Total Hip Arthroplasty
Scientific Title:Acronym Clinical Study on the Efficacy and Safety of Z101101 in Total Hip Arthroplasty
Region
Japan

Condition
Condition Patients who have been judged to require THA
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are to evaluate the efficacy and safety of Z101101 when used in subjects requiring primary total hip arthroplasty (THA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 1) Improvement ratings: Evaluated based on changes in JOA scores at 6 months post-THA from baseline (before THA) according to the criteria .
2) Safety ratings : Evaluated based on details of failures/device-related adverse events (including revision cases) reported during 6 months post-THA according to the criteria.
Key secondary outcomes Evaluations at 6 months post-THA
1) Safety ratings.
2) Morphological stability.
3) Improvements in JOA scores and SF-12 (QOL) questionnaire scores.

Evaluations at 2 years of follow-up
1) Failures/adverse events.
2) Morphological stability.
3) Improvements in JOA scores and SF-12 (QOL) questionnaire scores.

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 Implantation of components 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
21 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patient is skeletally mature.
2) The patient has a JOA Pain Score =< 20 and a JOA Total Score =< 50, and has been diagnosed to require THA.
3) The patient has one or more of the following diseases that require THA:
(1) Osteonecrosis of the femoral head
(2) Osteoarthritis
(3) Rheumatoid arthritis
4) The patient has not had THA or arthrodesis.
5) The patient is able to provide his/her own consent to participate in the study in a written form.
Key exclusion criteria 1) The patient is a known alcohol or drug abuser.
2) The patient has a neuromuscular disorder, vascular disorder or other condition that could cause implant instability, implant fixation failure, or postoperative complications.
3) The patient has a vascular insufficiency (large and small vessel disease), renal impairment, or renal failure.
4) The patient has initiated a chronic administration of systemic or inhaled steroid within 3 months.
5) The patient has a neurologic condition that could affect the function of the lower limbs.
6) The patient needs to be corrected a leg length discrepancy >= 3.2 cm.
7) The patient has a systemic disease that could affect his/her safety or the study outcome.
8) The patient has a contagious disease and is difficult to continue observation/investigation.
9) The patient is known to be pregnant.
10) The patient has received an investigational drug or other investigational device within the previous 6 months.
11) The patient has an active or latent infection in or about the affected hip joint or an infection distant from the affected hip joint that may spread to the affected joint hematogenously.
12) The patient has a known sensitivity or allergic reaction to any of the materials of the joint prosthesis including metal and ceramic.
13) The patient has an acute fracture in the affected femoral head that requires THA.
14) The patient has undergone THA, revision surgery or surface arthroplasty of the contralateral hip within the previous 6 months.
15) The patient has had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
16) The patient has insufficient bone stock to fix the hip prostheses.
17) The patient has a local bone tumor or cyst in the affected hip joint.
18) The patient has a Body Mass Index (BMI) >35.
Target sample size 69

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikiharu Morita
Organization Zimmer K.K.
Division name Clinical Research Dept.
Zip code
Address 1-17, Toranomon 4-chome, Minato-ku, Tokyo 105-0001, Japan
TEL 03-6402-6764
Email mikiharu.morita@zimmer.com

Public contact
Name of contact person
1st name
Middle name
Last name Mikiharu Morita
Organization Zimmer K.K.
Division name Clinical Research Dept.
Zip code
Address 1-17, Toranomon 4-chome, Minato-ku, Tokyo 105-0001, Japan
TEL 03-6402-6764
Homepage URL
Email mikiharu.morita@zimmer.com

Sponsor
Institute Zimmer K.K.
Institute
Department

Funding Source
Organization Zimmer K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 海老名総合病院 人工関節・リウマチセンター (神奈川県)、JR東京総合病院 (東京都)、東京警察病院 (東京都)
Institute of joint Replacement and Rheumatology, Ebina General Hospital (Kanagawa), JR Tokyo General Hospital (Tokyo), Tokyo Metropolitan Police Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 14 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 12 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2013 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 27 Day
Last modified on
2014 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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