Custom made LLIF artificial bone

JRCT ID: jRCTs052210067

Registered date:19/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Degenerative lumbar diseases
• Date of first enrollment: 15/11/2021
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Perform lumbar spine surgery using patient-specific artificial bone, which is an unapproved medical device, and follow up for 1 year after surgery.operative intervention

Outcome(s)

Primary Outcome

1)Occurrence of adverse events
2)Improvement of symptoms

Secondary Outcome

1)Avoiding autologous iliac bone graft
2)Proper placement of test device
3)Bony union of test device
4)Acquisition and maintenance of spinal alignment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both
• Include criteria: The main complaints are lumbar disc disease, lumbar spondylolisthesis, lumbar spinal canal stenosis, low back pain due to osteoporotic vertebral body fracture, nerve root symptoms, and cauda equina symptoms that do not improve with conservative treatment (physical therapy or drug therapy) for 3 months or longer. Cases for which LLIF surgery is indicated and shape compatibility cannot be obtained with existing cages.

Exclude criteria

Other spinal lesions such as cervical and thoracic spine disorders that require treatment
Systemic autoimmune diseases such as rheumatoid arthritis
Complications that are judged to seriously interfere with the execution of clinical trials (uncontrollable diabetes and hypertension, serious heart disease, respiratory disease, etc.)
Malignant tumor with no disease period within 5 years
Mental illness or psychiatric symptoms that may be difficult to participate in clinical trials
Bacterial infectious diseases of clinical problem
Diseases that require continuous systemic administration of steroids

Related Information

• Primary Sponsor: Fujibayashi Shunsuke
• Secondary Sponsor: G-Cube Co., Ltd.,Kyoto University Incubation Program