Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects
NCT ID: NCT04980261
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2020-07-01
2022-12-31
Brief Summary
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Detailed Description
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Bovine hydroxyapatite (BHA) is a xenograft (animal-derived graft) with osteoconductive properties. Simultaneously, the secretome of the mesenchymal stem cells contains cytokines, chemokines, and growth factors, which possess osteoinductive properties. Thus, we hypothesize that the combination (composite) of BHA/secretome (in the form of freeze-dried (FD) BHA/secretome composite) will promote bone healing ability that is equal to autografts while eliminating donor-site morbidity in the patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control Group (ORIF + autograft)
The patients will receive the current gold standard to treat long bone defects.
ORIF + autograft
Patients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest).
Treatment Group (ORIF + FD BHA/Secretome composite)
The patients will receive a novel bone substitute following the ORIF procedure.
ORIF + FD BHA/Secretome
Patients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation.
Interventions
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ORIF + autograft
Patients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest).
ORIF + FD BHA/Secretome
Patients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation.
Eligibility Criteria
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Inclusion Criteria
* No history of comorbid diseases
* Willing to be involved in the clinical trial
Exclusion Criteria
* Suffered from multiple fractures and multitrauma patients
* Loss to follow-up
18 Years
50 Years
ALL
No
Sponsors
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Dr. Ramelan Naval Hospital
UNKNOWN
Airlangga University Hospital
UNKNOWN
Sidoarjo General Hospital
UNKNOWN
Cell & Tissue Bank, Dr. Soetomo General Hospital
UNKNOWN
Dr. Soetomo General Hospital
OTHER_GOV
Responsible Party
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Locations
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Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0045/KEPK/VIII/2020
Identifier Type: -
Identifier Source: org_study_id
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