UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Morio Matsumoto
Organization	Keio University Hospital
Division name	Department of orthopaedic surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL	03-3353-1211
Email	morio@keio.co.jp

Public contact
Name of contact person	Morio Matsumoto
Organization	Keio University Hospital
Division name	Department of orthopaedic surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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