UMIN-CTR Clinical Trial

Basic information
Public title	Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-
Acronym	TM Stem Registry Study -Multicenter clinical research in Japan and US
Scientific Title	Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-
Scientific Title:Acronym	TM Stem Registry Study -Multicenter clinical research in Japan and US
Region	Japan North America

Condition
Condition	Patients who have been diagnosed Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, etc.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To obtain preoperative, operative and postoperative clinical outcomes and radiographic data on the Trabecular Metal Primary Hip Prosthesis used in primary or revision total hip arthroplasty.
Basic objectives2	Others
Basic objectives -Others	To pool the clinical data.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To obtain preoperative, operative and postoperative clinical outcomes and radiographic data
Key secondary outcomes

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	Trabecular Metal Primary Hip Prosthesis 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.atient is &#8805; 18 years of age. 2.Patient is in stable health and able to undergo surgery. 3.Patient suffers from severe hip pain and disability requiring total, hemi or revision hip replacement. 4.Patient is willing and able to cooperate in prescribed post-operative therapy. 5.Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. 6.Patient has participated in the Informed Consent process and has signed an IRB approved Informed Consent.
Key exclusion criteria	1.Patient is &#8805; 18 years of age. 2.Patient with an acute, chronic, local or systemic infection. 3.Patient is skeletally immature. 4.Patient is pregnant. 5.Patient is a prisoner, mentally incompetent and/or anticipated to be non-compliant. 6.Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Hirakawa
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Orthopaedic Surgery
Zip code	247-0061
Address	5-4-17, Dai, Kamakura, Kanagawa prefecture, Japan
TEL	0467-47-2377
Email	mail@skjrc.jp

Public contact
Name of contact person	1st name Kazuo Middle name Last name Hirakawa
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Orthopaedic Surgery
Zip code	247-0061
Address	5-4-17, Dai, Kamakura, Kanagawa prefecture, Japan
TEL	0467-47-2377
Homepage URL
Email	akikun@jcom.home.ne.jp

Sponsor
Institute	Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization	Zimmer Inc.
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	Mirai Iryo Research Center
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	0332634801
Email	mirai-ec1@mirai-iryo.com

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

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 04 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	2011 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 11 Month 02 Day
Last modified on	2020 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007866