NCT04980261

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

July 18, 2021

Last Update Submit

July 18, 2021

Conditions

Bone Loss

Keywords

Bone DefectsBone SubstitutesHydroxyapatitesMesenchymal Stem CellsSecretome

Outcome Measures

Primary Outcomes (10)

  • X-ray evaluation immediately following surgery.

    A two-view (anterior-posterior/AP and lateral) radiograph will be taken immediately following surgery. The x-ray evaluation will be carried out by a blinded outcome assessor using a scoring system named Radiographic Union Score (Whelan et al., 2010) to assess bone union based on fracture line, callus, and graft resorption on plain radiograph after fracture. This score ranges from 4 to 12, with a higher score indicating a more favorable outcome (better bone healing).

    Day-0

  • X-ray evaluation at 4 weeks following surgery

    A two-view (anterior-posterior/AP and lateral) radiograph will be taken immediately following surgery. The x-ray evaluation will be carried out by a blinded outcome assessor using a scoring system named Radiographic Union Score (Whelan et al., 2010) to assess bone union based on fracture line, callus, and graft resorption on plain radiograph after fracture. This score ranges from 4 to 12, with a higher score indicating a more favorable outcome (better bone healing).

    4 weeks

  • X-ray evaluation at 8 weeks following surgery.

    A two-view (anterior-posterior/AP and lateral) radiograph will be taken immediately following surgery. The x-ray evaluation will be carried out by a blinded outcome assessor using a scoring system named Radiographic Union Score (Whelan et al., 2010) to assess bone union based on fracture line, callus, and graft resorption on plain radiograph after fracture. This score ranges from 4 to 12, with a higher score indicating a more favorable outcome (better bone healing).

    8 weeks

  • X-ray evaluation at 12 weeks following surgery.

    A two-view (anterior-posterior/AP and lateral) radiograph will be taken immediately following surgery. The x-ray evaluation will be carried out by a blinded outcome assessor using a scoring system named Radiographic Union Score (Whelan et al., 2010) to assess bone union based on fracture line, callus, and graft resorption on plain radiograph after fracture. This score ranges from 4 to 12, with a higher score indicating a more favorable outcome (better bone healing).

    12 weeks

  • X-ray evaluation at 16 weeks following surgery.

    A two-view (anterior-posterior/AP and lateral) radiograph will be taken immediately following surgery. The x-ray evaluation will be carried out by a blinded outcome assessor using a scoring system named Radiographic Union Score (Whelan et al., 2010) to assess bone union based on fracture line, callus, and graft resorption on plain radiograph after fracture. This score ranges from 4 to 12, with a higher score indicating a more favorable outcome (better bone healing).

    16 weeks

  • Ultrasonography evaluation at 2 weeks

    A blinded outcome assessor will perform ultrasonography (USG) evaluation to assess the four stages of the bone healing process using a scoring system named Sonographic Union Score developed by our institution. We will evaluate the following parameters: (1) hematoma organization, (2) neovascularization, (3) bone fracture tip echogenicity, (4) bone fracture border, (5) bridging callus echogenicity, (6) bone to bone graft junction gap, (7) callus formation mineralization, (8) bone surface continuity.

    2 weeks

  • Ultrasonography evaluation at 4 weeks

    A blinded outcome assessor will perform ultrasonography (USG) evaluation to assess the four stages of the bone healing process using a scoring system named Sonographic Union Score developed by our institution. We will evaluate the following parameters: (1) hematoma organization, (2) neovascularization, (3) bone fracture tip echogenicity, (4) bone fracture border, (5) bridging callus echogenicity, (6) bone to bone graft junction gap, (7) callus formation mineralization, (8) bone surface continuity.

    4 weeks

  • Ultrasonography evaluation at 8 weeks

    A blinded outcome assessor will perform ultrasonography (USG) evaluation to assess the four stages of the bone healing process using a scoring system named Sonographic Union Score developed by our institution. We will evaluate the following parameters: (1) hematoma organization, (2) neovascularization, (3) bone fracture tip echogenicity, (4) bone fracture border, (5) bridging callus echogenicity, (6) bone to bone graft junction gap, (7) callus formation mineralization, (8) bone surface continuity.

    8 weeks

  • Ultrasonography evaluation at 12 weeks

    A blinded outcome assessor will perform ultrasonography (USG) evaluation to assess the four stages of the bone healing process using a scoring system named Sonographic Union Score developed by our institution. We will evaluate the following parameters: (1) hematoma organization, (2) neovascularization, (3) bone fracture tip echogenicity, (4) bone fracture border, (5) bridging callus echogenicity, (6) bone to bone graft junction gap, (7) callus formation mineralization, (8) bone surface continuity.

    12 weeks

  • Ultrasonography evaluation at 16 weeks

    A blinded outcome assessor will perform ultrasonography (USG) evaluation to assess the four stages of the bone healing process using a scoring system named Sonographic Union Score developed by our institution. We will evaluate the following parameters: (1) hematoma organization, (2) neovascularization, (3) bone fracture tip echogenicity, (4) bone fracture border, (5) bridging callus echogenicity, (6) bone to bone graft junction gap, (7) callus formation mineralization, (8) bone surface continuity.

    16 weeks

Secondary Outcomes (3)

  • Functional evaluation at 8 weeks following surgery.

    8 weeks

  • Functional evaluation at 12 weeks following surgery.

    12 weeks

  • Functional evaluation at 16 weeks following surgery.

    16 weeks

Study Arms (2)

Control Group (ORIF + autograft)

ACTIVE COMPARATOR

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

Procedure: ORIF + autograft

Treatment Group (ORIF + FD BHA/Secretome composite)

EXPERIMENTAL

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

Procedure: ORIF + FD BHA/Secretome

Interventions

ORIF + autograftPROCEDURE

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

Control Group (ORIF + autograft)
ORIF + FD BHA/SecretomePROCEDURE

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

Treatment Group (ORIF + FD BHA/Secretome composite)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 60286, Indonesia

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Central Study Contacts

Ferdiansyah Mahyudin, MD, Ph.D

CONTACT

+62811320635ferdyortho@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2021

First Posted

July 28, 2021

Study Start

July 1, 2020

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

July 28, 2021

Record last verified: 2021-04

Locations

ID(1)