UMIN-CTR Clinical Trial

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
Email	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
Email	sakurs2@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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034569