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
Qualifiers
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
Treatments tested in this trial
- MDT-0123
- ICBG
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov