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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030267
Receipt No. R000034569
Scientific Title PRESTIGE LP Cervical Disc System (1 level) Regulated PMS
Date of disclosure of the study information 2017/12/14
Last modified on 2019/12/18

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Basic information
Public title PRESTIGE LP Cervical Disc System (1 level) Regulated PMS
Acronym PRESTIGE LP Cervical Disc System (1 level) Regulated PMS
Scientific Title PRESTIGE LP Cervical Disc System (1 level) Regulated PMS
Scientific Title:Acronym PRESTIGE LP Cervical Disc System (1 level) Regulated PMS
Region
Japan

Condition
Condition Single-level radiculopathy or myelopathy involving herniated disk or osteophyte formation
Classification by specialty
Orthopedics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this use results survey is to assess the safety and efficacy of ''PRESTIGE LP Cervical Disc System'' (hereafter referred to as ''the product'' in treatment of the patients unresponsive to non-operative therapy of at least three months with single-level radiculopathy or myelopathy involving herniated disc or osteophyte formation observed under imaging tests.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Among adverse events/deficiencies, secondary surgeries and implant-related events (subsidence, migration, etc.)
(1) Secondary surgery
Surgical procedures at the treated level, including revision, removal, supplemental fixation and reoperation
(2) Implant-related event
Subsidence of implant, fall of implant, migration of implant, or other implant-related event
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1 Not applicable <=
Age-upper limit
100 Not applicable >=
Gender Male and Female
Key inclusion criteria Patients unresponsive to non-operative therapy of at least three months with single-level radiculopathy or myelopathy involving herniated disc or osteophyte formation observed under imaging tests.
Key exclusion criteria 1) Patients allergic to metals
2) Patients in the process of active infection, or with a serious risk of infection such as an immunodeficiency
3) Patients with a disease that involves severe bone fragility, (or with a cervical vertebra so fragile as to experience difficulty in receiving an implant due to diseases such as severe osteoporosis, osteomalacia, Paget's disease of bone, renal osteodystrophy, Ehlers-Danlos Syndrome, osteogenesis imperfecta, etc.)
4) Patients with notable cervical instability under the lateral images of ante-/retro-flexion
5) Patients with either of the following severe cervical diseases:
(1) Bridging osteophyte formation observed at the treated level without maintaining mobility
(2) Significantly-narrowing intervertebral height observed at the treated level
6) Patients with a severe facet joint arthrosis at the treated level
7) Patients with a significant lesion or deformity of vertebral body
8) Patients presenting obvious abnormality in cervical alignment (e.g. local kyphosis)
9) Patients presenting an obvious cervical spinal canal stenosis across multiple levels
10) Patients with a trauma involving cervical bone fracture, ligament injury, etc.
11) Patients presenting obvious involuntary movement at the head and neck area
Target sample size 67

Research contact person
Name of lead principal investigator
1st name Asami
Middle name
Last name Taguchi
Organization Medtronic Sofamor Danek, Co., Ltd.
Division name Clinical
Zip code 108-0075
Address Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo 108-0075 Japan
TEL 03-6776-0018
Email asami.taguchi@medtronic.com

Public contact
Name of contact person
1st name Asami
Middle name
Last name Taguchi
Organization Medtronic Sofamor Danek, Co., Ltd.
Division name Clinical
Zip code 108-0075
Address Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo 108-0075 Japan
TEL 03-6776-0018
Homepage URL
Email asami.taguchi@medtronic.com

Sponsor
Institute Medtronic Sofamor Danek, Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University Hospital
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-4575
Email mkan-rinsho.adm@tmd.ac.jp

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

Other administrative information
Date of disclosure of the study information
2017 Year 12 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 20 Day
Date of IRB
2017 Year 11 Month 27 Day
Anticipated trial start date
2017 Year 12 Month 14 Day
Last follow-up date
2021 Year 12 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 05 Day
Last modified on
2019 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034569

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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