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Clinical Trials/JPRN-jRCTs052210067
JPRN-jRCTs052210067
Completed
未知

Clinical trial on the safety and efficacy of lateral lumbar fusion using a custom-made porous titanium artificial bone

Fujibayashi Shunsuke0 sites3 target enrollmentAugust 19, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Degenerative lumbar diseases
Sponsor
Fujibayashi Shunsuke
Enrollment
3
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 19, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Fujibayashi Shunsuke

Eligibility Criteria

Inclusion 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.

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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