UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004797 |
|---|---|
| Receipt number | 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 09:55:26 |
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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
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
mikiharu.morita@zimmer.com
Sponsor or person
Institute
Zimmer K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005710
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| Registered date | File name |
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