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Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects

NCT04980261 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Bone Loss

Interventions

PROCEDURE

ORIF + autograft

Patients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest).

PROCEDURE

ORIF + FD BHA/Secretome

Patients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation.

Sponsors & Collaborators

  • Dr. Ramelan Naval Hospital

    collaborator UNKNOWN

  • Airlangga University Hospital

    collaborator UNKNOWN

  • Sidoarjo General Hospital

    collaborator UNKNOWN

  • Cell & Tissue Bank, Dr. Soetomo General Hospital

    collaborator UNKNOWN

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-07-01
Completion
2022-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980261 on ClinicalTrials.gov