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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027744
Receipt No. R000031751
Scientific Title Multicentre, prospective, randomised clinical survey to evaluate early fusion rate after instrumented lumbar stabilization with either MectaLIF PEEK lumbar cage or MectaLIF TiPEEK lumbar cage
Date of disclosure of the study information 2017/06/15
Last modified on 2017/06/13

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Basic information
Public title Multicentre, prospective, randomised clinical survey to evaluate early fusion rate after instrumented lumbar stabilization with either MectaLIF PEEK lumbar cage or MectaLIF TiPEEK lumbar cage
Acronym Study to evaluate early fusion rate using MectaLIF PEEK or MectaLIF TiPEEK lumbar cage
Scientific Title Multicentre, prospective, randomised clinical survey to evaluate early fusion rate after instrumented lumbar stabilization with either MectaLIF PEEK lumbar cage or MectaLIF TiPEEK lumbar cage
Scientific Title:Acronym Study to evaluate early fusion rate using MectaLIF PEEK or MectaLIF TiPEEK lumbar cage
Region
Japan

Condition
Condition Disorders that are treated with lumbar intervertebral body fusion, such as lumbar spondylolisthesis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study aims to demonstrate that the TiPEEK device, thanks to the titanium coating, provides a higher fusion rate compared to a PEEK surface at 6 months follow-up.
Basic objectives2 Others
Basic objectives -Others superiority
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Thin-slice CT to assess fusion rate and cage subsidence
Key secondary outcomes - Clinical and functional assessment of the involved hip according to the ODI Index, VAS pain and JOA Back Pain Evaluation Questionnaire
- Flexion/extension x-rays for functional assessment
- Standard AP and lateral x-rays
- CT Scan
- Full spinal column X rays
- MRI
- Recording of Adverse Events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 MectaLIF PEEK Cage (Oblique or Posterior Cage)

- Depending on the patient, cages will be implanted into 1 or 2 intervertebral levels.
-In general, the Oblique cage will be implanted. But if a cage size of under 28mm is judged to be appropriate, then the Posterior cage will be used. The make and properties of the Posterior cage are the same as the Oblique cage.
-As the medical device is a spinal implant,it will remain in the body following the procedure.
Interventions/Control_2 MectaLIF TiPEEK Cage (Oblique or Posterior Cage)

- Depending on the patient, cages will be implanted into 1 or 2 intervertebral levels.
-In general the Oblique cage will be implanted. But if a cage size of under 28mm is judged to be appropriate, then the Posterior cage will be used. The make and properties of the Posterior cage are the same as the Oblique cage.
-As the medical device is a spinal implant,it will remain in the body following the procedure.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria - Patients requiring lumbar intervertebral body fusion (according to the label indication/contraindications).
- Patients requiring one or two-level fusion (level under evaluation L3-L4/L4-L5/L5-S1).
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.
- Patients showing a level of Bone Mineral Density higher than 70% YAM on both vertebrae adjacent to each index level.
Key exclusion criteria - Patients with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism.
- Patients who are currently taking teriparatide or denosumab.
- Patients who have taken teriparatide within 1 month.
- Patients who have taken denosumab within 6 months.
- Patients with neuromuscular disorders such as Parkinson's disease or athetosis.
- Patients who are on dialysis.
- Patients with previous spine surgeries at the level, excepting those who underwent decompression and/or nucleotomies.
- Patients with restricted mobility.
- Patients who are deemed unfit for participation by the Principal Investigator or the Sub-Investigators.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morio Matsumoto
Organization Keio University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Email morio@keio.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morio Matsumoto
Organization Keio University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Homepage URL
Email morio@keio.co.jp

Sponsor
Institute INCREASE Co., Ltd.
Institute
Department

Funding Source
Organization Medacta International SA
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Switzerland

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 Month 15 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 13 Day
Last modified on
2017 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031751

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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