MDT-0123 Japan Study
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedtronic Spinal and Biologics
About this trial
The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two levels (ALIF or OLIF) due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) for intervertebral support and correction with the aim of stabilizing the spine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Requirement for bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1)
Symptomatic degenerative lesions from L2 to S1 confirmed by imaging (MRI or myelography within 12 months prior to enrollment) with neurological symptoms due to nerve root compression, including radiating pain, sensory disturbance, numbness, weakness, or neurogenic claudication
Degenerative disc disease with discogenic back pain, with or without leg pain, supported by clinical history and radiographic findings (e.g., CT, MRI, X-ray), with at least one of the following: instability (angular motion ≥5° and/or translation ≥4 mm), osteophyte formation, decreased intervertebral disc height, ligamentous thickening, disc degeneration or herniation, or facet joint degeneration
Preoperative Oswestry Disability Index (ODI) score ≥35%
Disqualifiers
Prior spinal surgery at the target or adjacent intervertebral level, except for decompression procedures such as discectomy
Inability to complete both investigational device implantation and posterior fixation in a single procedure
Expected total rhBMP-2 dose greater than 12 mg
Planned use of an internal or external bone growth stimulator
Trial design
Design model
Parallel
Treatments tested in this trial
MDT-0123
Combination productUse a combination of the MDT-0123 spine cage and the MDT-0123 kit.
ICBG
DeviceUse a combination of the MDT-0123 spine cage and ICBG
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: MDT-0123Active comparator 1 intervention
Group B: Iliac bone graft (ICBG)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary endpoints of efficacy
Bone fusion status 12 months visit after index procedure The success rate of bone fusion at the 12-month visit after the index procedure will be evaluated. Imaging evaluations will be performed at baseline, after the index procedure (to discharge), at 3, 6, and 12 months (CT scan will be performed at baseline, 6, and 12 months only), and imaging evaluation for the primary efficacy endpoint will be performed by the core laboratory at the 12-month visit. Primary endpoints
Time frame
12 months2
Primary endpoints of safety
Incidence of Adverse Device Effects in both groups up to 12 months post index procedure. To evaluate the rate of subjects experiencing any adverse device effects in both groups that occurring up to 12-month visit after the index procedure.
Time frame
12monthsSecondary outcomes
1
Change in disc height at the 12-month visit compared to the measurements taken within 14 days after the index procedure.
The height of the intervertebral disc measured by x-ray in the standing position. The calculation method uses (anterior disc height + central disc height + posterior disc height) divided by the anteroposterior diameter of the vertebral body. Preoperative measurements are conducted to understand the subject's pathological condition. 2） Change of General health condition at follow-
Time frame
From 14 days after the index procedure to 12months2
Change of General health condition at follow-ups from baseline at 12months.
Medical Outcomes Study 36-ltem Short Form Health Survey (SF-36) was used to assess the general health status of the subjects. The results of SF-36 can be summarized into two components: physical element summary (PCS) and mental element summary (MCS).
Time frame
From baseline to 12months3
Change of OSWESTRY DISABILITY INDEX (ODI) at follow-ups from baseline at month 12.
Using the ODI, calculate and evaluate each score for the 10 sections (pain intensity, self-care, raising the object, etc.)
Time frame
From baseline to 12Months4
Change of Lower back pain at follow-ups from baseline at 12months
The numerical rating scale (Numerical Rating Scale (NRS)) used to evaluate lower back pain using a score of 0-10.
Time frame
From baseline to 12monthsSponsors and contacts
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Source ClinicalTrials.gov