UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027744 |
|---|---|
| Receipt number | 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 20:45:48 |
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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
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
morio@keio.co.jp
Sponsor or person
Institute
INCREASE Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031751
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| Registered date | File name |
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| Registered date | File name |
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