UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030267 |
|---|---|
| Receipt number | 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 | 2022/12/09 16:11:48 |
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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 | Akira |
| Middle name | |
| Last name | Kikuchi |
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
03-6776-0007
akira.kikuchi@medtronic.com
Public contact
Name of contact person
| 1st name | Shigeaki |
| Middle name | |
| Last name | Sakurai |
Organization
Medtronic Japan Co., Ltd.
Division name
Japan Clinical and Medical Affairs
Zip code
108-0075
Address
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo 108-0075 Japan
TEL
03-6776-1406
Homepage URL
sakurs2@medtronic.com
Sponsor or person
Institute
Medtronic Sofamor Danek, Co., Ltd.
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 02 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 04 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 25 | Day |
Other
Other related information
End of Survey on the Results of Usage period
Management information
Registered date
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034569
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