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Clinical Trials/JPRN-jRCT2080225010
JPRN-jRCT2080225010
Completed
Phase 1

Phase I/II study to investigate safety and effectiveness at surgery using OIF/KX for patients with nonunion in femur, tibia or humerus.

Osteopharma Inc.0 sites8 target enrollmentJanuary 8, 2020
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Conditionsnonunion in femur, tibia or humerus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
nonunion in femur, tibia or humerus
Sponsor
Osteopharma Inc.
Enrollment
8
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 8, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Osteopharma Inc.

Eligibility Criteria

Inclusion Criteria

  • •1\. The subject is 20 to 70 years old (when obtaining informed consent)
  • •2\. Patients with nonunion fracture in femur, tibia, or hummerus have been in nonunion for more 6 months since the fracture injury or the previous nonunion surgery, and need the surgery of autologous bonegraft.
  • •3\. Patients who are categorized to noninfected nonunion or non drainage and non active infected nonunion in Muller classification.
  • •4\. Patients who have general condition enough to undergo surgery, and are permitted to participate in the clinical study by investigator.
  • •5\. Patients who can understand the informed consent form and are willing to provide signature.

Exclusion Criteria

  • •Subjects will be excluded if ANY of the following exclusion criteria apply
  • •1\.Congenital pseudoarthrosis
  • •2\.Multiple pseudoarthrosis
  • •3\.Under radiation therapy, chemical therapy, or taking immunosuppressant
  • •4\.With movement paralysis in upper limb or lower limb of treatment (paralysis in lower limbs due to cerebral infarction, spinal cord injury, etc.)
  • •5\.Allergy or hypersensitive to calcium phosphatic
  • •6\.Malignant tumor or less than 5 years recurrence period after cancer treatment
  • •7\.Diabetes with uncontrollable blood glucose level medically by judgement of doctor.
  • •8\.Unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage or transient ischemic attack less than 3 months after onset
  • •9\.Severe liver, renal, or heart disease

Outcomes

Primary Outcomes

Not specified

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