Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects

Dr. Soetomo General Hospital

Status: Unknown

Conditions: Bone Loss

Treatments: Procedure: ORIF + FD BHA/Secretome; Procedure: ORIF + autograft

Study type: Interventional

Funder types: Other

Identifiers

NCT04980261

0045/KEPK/VIII/2020

Details and patient eligibility

About

This clinical trial aims to investigate the efficacy of freeze-dried bovine hydroxyapatite/secretome composite application for the management of long bone defects and other bone healing disorders in the lower extremities.

Full description

The gold standard for treating bone defect conditions is autologous bone graft (autograft). Autograft promotes bone healing due to its osteoconductive (serving as a foundation that facilitates bone growth), osteoinductive (stimulates progenitor cells), and osteogenesis (acting as a precursor of osteoblasts and osteoclasts) properties. However, donor site morbidity and persisting pain following harvest remains a major problem. Hence, we attempt to investigate the efficacy of other bone substitutes, i.e., bovine hydroxyapatite/secretome composite, to treat long bone defects and other bone healing disorders in the lower extremities.

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with bone defects (less than 5 cm) in the diaphysis of the long bones of the lower extremities due to trauma and other bone healing disorders
• No history of comorbid diseases
• Willing to be involved in the clinical trial

Exclusion criteria

• Patients with bone defects or impaired bone healing caused by tumors, infections, and metabolic diseases
• Suffered from multiple fractures and multitrauma patients
• Loss to follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

Control Group (ORIF + autograft)

Active Comparator group

Description:

The patients will receive the current gold standard to treat long bone defects.

Treatment:

Procedure: ORIF + autograft

Treatment Group (ORIF + FD BHA/Secretome composite)

Experimental group

Description:

The patients will receive a novel bone substitute following the ORIF procedure.

Treatment:

Procedure: ORIF + FD BHA/Secretome