Bone LossNCT04980261
Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects
A study testing ORIF + autograft and ORIF + FD BHA/Secretome in people with Bone Loss, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- ORIF + autograft and ORIF + FD BHA/Secretome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Soetomo General Hospital
Surabaya, East Java, 60286
Ferdiansyah Mahyudin, MD, Ph.D, 0811320635, ferdyortho@yahoo.com
About this study
Official title: Clinical Trial of Freeze-dried Bovine Hydroxyapatite/Secretome Composite Application for the Management of Long Bone Defects in the Lower Extremities
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.
Read the detailed 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.
- Conditions
- Bone Loss
- Being tested
- ORIF + autograft, ORIF + FD BHA/Secretome
- Keywords
- Bone Defects, Bone Substitutes, Hydroxyapatites, Mesenchymal Stem Cells, Secretome
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIF + autograftProcedure or surgery
Patients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest).
ORIF + FD BHA/SecretomeProcedure or surgery
Patients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (ORIF + autograft) | Active comparator | The patients will receive the current gold standard to treat long bone defects. Receives: Procedure: ORIF + autograft |
| Treatment Group (ORIF + FD BHA/Secretome composite) | Experimental | The patients will receive a novel bone substitute following the ORIF procedure. Receives: Procedure: ORIF + FD BHA/Secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (3)
Functional evaluation at 8 weeks following surgery.
The functional evaluation will be assessed by using a scoring system named LEFS (Lower Extremity Functional Scale). LEFS is a widely known and validated patient-reported outcome measures (PROM) comprising 20 questions that is used to assess lower extremity functions. The patients will be asked to rate the activity listed from 0 to 4 (0 refers to an extreme difficulty/unable to perform activity, while 4 refers to having no difficulty at all). A higher score (maximum 80 points) indicates a very high function (i.e., a more favorable outcome).
Measured: 8 weeks
Functional evaluation at 12 weeks following surgery.
The functional evaluation will be assessed by using a scoring system named LEFS (Lower Extremity Functional Scale). LEFS is a widely known and validated patient-reported outcome measures (PROM) comprising 20 questions that is used to assess lower extremity functions. The patients will be asked to rate the activity listed from 0 to 4 (0 refers to an extreme difficulty/unable to perform activity, while 4 refers to having no difficulty at all). A higher score (maximum 80 points) indicates a very high function (i.e., a more favorable outcome).
Measured: 12 weeks
Functional evaluation at 16 weeks following surgery.
The functional evaluation will be assessed by using a scoring system named LEFS (Lower Extremity Functional Scale). LEFS is a widely known and validated patient-reported outcome measures (PROM) comprising 20 questions that is used to assess lower extremity functions. The patients will be asked to rate the activity listed from 0 to 4 (0 refers to an extreme difficulty/unable to perform activity, while 4 refers to having no difficulty at all). A higher score (maximum 80 points) indicates a very high function (i.e., a more favorable outcome).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Collaborators
- Dr. Ramelan Naval Hospital, Airlangga University Hospital, Sidoarjo General Hospital, Cell & Tissue Bank, Dr. Soetomo General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980261
- Sponsor's protocol ID
- 0045/KEPK/VIII/2020
- Status last verified
- Apr 2021
- First submitted
- 18 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Freeze-dried Bovine Hydroxyapatite/Secretome Composite Application for the Management of Long Bone Defects in the Lower Extremities
- ClinicalTrials.gov ID
- NCT04980261
- Acronym / sponsor ID
- 0045/KEPK/VIII/2020
- Conditions
- Bone Loss
- Keywords
- Bone Defects, Bone Substitutes, Hydroxyapatites, Mesenchymal Stem Cells, Secretome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Collaborators
- Dr. Ramelan Naval Hospital, Airlangga University Hospital, Sidoarjo General Hospital, Cell & Tissue Bank, Dr. Soetomo General Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (ORIF + autograft) | Active comparator | Procedure: ORIF + autograftThe patients will receive the current gold standard to treat long bone defects. |
| Treatment Group (ORIF + FD BHA/Secretome composite) | Experimental | Procedure: ORIF + FD BHA/SecretomeThe patients will receive a novel bone substitute following the ORIF procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORIF + autograftPatients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest). | Procedure or surgery | Control Group (ORIF + autograft) |
| ORIF + FD BHA/SecretomePatients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation. | Procedure or surgery | Treatment Group (ORIF + FD BHA/Secretome composite) |
Primary outcome
X-ray evaluation immediately following surgery.
Time frame: Day-0
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).
X-ray evaluation at 4 weeks following surgery
Time frame: 4 weeks
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).
X-ray evaluation at 8 weeks following surgery.
Time frame: 8 weeks
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).
X-ray evaluation at 12 weeks following surgery.
Time frame: 12 weeks
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).
X-ray evaluation at 16 weeks following surgery.
Time frame: 16 weeks
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).
Ultrasonography evaluation at 2 weeks
Time frame: 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.
Ultrasonography evaluation at 4 weeks
Time frame: 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.
Ultrasonography evaluation at 8 weeks
Time frame: 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.
Ultrasonography evaluation at 12 weeks
Time frame: 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.
Ultrasonography evaluation at 16 weeks
Time frame: 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.
3 secondary outcomes
Functional evaluation at 8 weeks following surgery.
Time frame: 8 weeks
Functional evaluation at 12 weeks following surgery.
Time frame: 12 weeks
Functional evaluation at 16 weeks following surgery.
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Related trials for Bone Loss
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF + autograft and ORIF + FD BHA/Secretome in people with Bone Loss, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferdiansyah Mahyudin, MD, Ph.D (+62811320635, ferdyortho@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
X-ray evaluation immediately following surgery. (time frame: Day-0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.