Two-Level Spinal Fusion for Disc Degeneration or Deformity: MDT-0123 compared with Autologous Bone Graft

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multi-center, open-label, randomized trial compares an investigational device MDT-0123 to autologous iliac bone graft (ICBG) for two-level lumbar fusion (L2-S1) in patients with disc degeneration or spinal deformity. Participants must require consecutive two-level fusion via ALIF or OLIF and have imaging-confirmed degenerative disease with nerve-related symptoms and a baseline ODI of 35% or higher. The study aims to determine the safety and efficacy of MDT-0123 as an alternative to ICBG in achieving intervertebral stability and symptom relief. It is a pre-market pivotal trial conducted at three Japanese centers and led by Medtronic Spinal and Biologics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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%
* Skeletally mature
* Age 18 to 80 years at the time of surgery
* Failure to respond to at least 3 months of non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, or transcutaneous electrical nerve stimulation)
* Ability to provide written informed consent after receiving adequate explanation of the study

Exclusion Criteria:

* 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
* Osteoporosis defined as T-score ≤ -2.5 within 12 months with fragility fracture
* Body mass index (BMI) \>40
* Active malignancy
* Active local or systemic infection
* Use of bone formation promoting agents within 12 months prior to implantation
* Use of medications that may interfere with bone or soft tissue healing within 30 days prior to implantation, including corticosteroids, antitumor agents, or immunosuppressants
* History of autoimmune diseases affecting bone metabolism or the spine, including ankylosing spondylitis, inflammatory bowel disease, or rheumatoid arthritis
* History of endocrine or metabolic disorders affecting bone formation, including Paget's disease or osteodystrophy
* Prior exposure to modified proteins used for bone formation
* Known hypersensitivity or allergy to device materials or related substances, including titanium, collagen, or protein-based products
* History of severe allergic reactions such as anaphylaxis
* Mental or psychiatric conditions that may interfere with study participation
* Participation in another clinical study within 3 months or planned participation during this study period
* Inability or unwillingness to use appropriate contraception during the study period and for 12 months after implantation
* Presence of spinal tumors in adjacent vertebrae
* Existing or planned implantation of non-study implants in the lumbosacral spine
* Medical conditions that could interfere with evaluation of safety or effectiveness, including significant vascular or anatomical abnormalities
* Contraindications to MRI
* Smoking within 12 weeks prior to implantation or unwillingness to abstain during the study period
* Alcohol or substance abuse
* Any condition that, in the investigator's judgment, makes the subject unsuitable for the study

Where it's running

• Kobe University Hospital
  Kobe, Hyōgo, Japan Recruiting
• Tokai University Hospital
  Isehara, Kanagawa, Japan Recruiting
• Wakakusa Daiichi Hospital
  Higashiosaka, Osaka, Japan Recruiting
• Dokkyo Medical University Saitama Medical Center
  Koshigaya, Saitama, Japan Recruiting
• Seirei Hamamatsu General Hospital
  Hamamatsu, Shizuoka, Japan Recruiting
• Sonoda Medical Corporations Sonoda Third Hospital
  Adachi-Ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Yuta Sekiguchi
• Email: yuta.sekiguchi@medtronic.com
• Phone: +818072088857

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two bioactive bone substitutes to help spinal fusion after anterior lumbar surgery

  This trial tests two osteoinductive bioactive bone substitutes to see which better helps adults with degenerative lumbar disc disease achieve spinal fusion after anterior lumbar interbody surgery.

  Recruiting University Hospital, Montpellier · Montpellier, France · NCT07044206

• Evaluating a new treatment for painful disc degeneration

  This study is testing a new non-surgical treatment for people with painful disc degeneration to see if it can help relieve their back pain when other treatments haven't worked.

  Recruiting at 19 sites VIVEX Biologics, Inc. · Napa, California and 18 other locations · NCT06778447

• Evaluation of 3D Digital Surgery in Traumatology

  This study is testing if using 3D digital surgery tools can help patients with orthopedic conditions have better surgery outcomes and fewer complications compared to traditional methods.

  Recruiting Corporacion Parc Tauli · Sabadell, Barcelona · NCT06603831

• Preoperative IV dexamethasone to reduce pain after minimally invasive lumbar fusion (MIS-TLIF)

  This trial will test whether a single intravenous dose of dexamethasone given before MIS-TLIF reduces postoperative back pain and opioid use in people aged 50–80 having 1–2 level lumbar fusion.

  Recruiting Phase 4 Thammasat University Hospital · Pathum Thani, Changwat Pathum Thani · NCT06367855

• Using ZetaFuse Bone Graft to treat cervical disc disease

  This study is testing if a new bone graft called ZetaFuse can help people with neck problems feel better and improve their nerve function after surgery.

  Recruiting at 2 sites Zetagen Therapeutics, Inc · Randwick, New South Wales and 1 other locations · NCT05971329

• Collecting data on Medtronic spinal devices after surgery

  This study is trying to see how well Medtronic spinal devices work and how safe they are for people after their surgery over the next two years.

  Recruiting at 28 sites Medtronic Spinal and Biologics · Tucson, Arizona and 28 other locations · NCT05856370

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.