Periosteal ElevationPhase 3NCT05270317
Bone Graft Cultivation by Periosteal Elevation
A Phase 3 study testing Bone Graft Cultivation and Harvesting in people with Periosteal Elevation, run by Jordanian Royal Medical Services at 1 site in Jordan.
Trial summary
Bone Graft Cultivation is a two-stage procedure aiming at generating new bone tissue for grafting by periosteal elevation . The first stage is the insertion of space-occupying implant which is responsible for keeping periosteal elevation for a defined time to stimulate new bone formation. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Periosteal Elevation
- What is being tested?
- Bone Graft Cultivation and Harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJordan
- Study dates
- 19 Dec 2021to 10 Mar 2023
- Phase
- Phase 3
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females with Bone loss pathologies.
- Males and females between one year and 14 years.
- post-traumatic, bone cysts or tumoral cases or post-infection and congenital pseudoarthrosis that requires bone grafting
Who cannot join
- Patients with systemic illness as cardiac diseases, or mental disorders or neuromuscular disorders \& hepatic patients (generally debilitating diseases).
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Royal Medical Services
Amman, 11732
Mutasem IM Aldhoon, MD, 00962777538242, Aldhoon12@yahoo.com
Mutasem Aldhoon, MD
About this study
Bone Graft Cultivation is a two-stage procedure aiming at generating new bone tissue for grafting by periosteal elevation . The first stage is the insertion of space-occupying implant which is responsible for keeping periosteal elevation for a defined time to stimulate new bone formation. The second stage is the extraction of woven bone that has been formed together with the implant. A sufficient amount of biologically highly valuable woven bone may be produced and harvested for bone grafting using periosteal elevation method. The concept of using periosteal elevation to cultivate bone has never mentioned in orthopedic literature.
Thus, this study aims to present an original experimental Interventional (Clinical Trial) on 18 skeletally immature patients. The purpose of this non-comparative study is to test, for the first time, possibility of generating bone tissue from iliac bone and to test the bioactivity of this new "Bone Graft Material" in fillings of losses of osseous substance from various origins, such as traumatic, infection, and benign tumoral causes.
Study protocol: Participants will be randomly assigned preoperatively into three surgical groups depending on cultivation time: early-stage group, medium-stage group and late-stage group . The newly bone formed bone will undergo tissue processing, and then, bone volume/tissue volume ratio, osteoid volume/tissue volume ratio, and osteocyte count per high-power field will be analyzed. In addition to histological examination, micro-CT scanning and osteoinductive factors ( bone morphogenic protein (BMP2), Fibroblast growth factor-2(FGF2), Transforming Growth Factor(TGFB1), and Insulin-like growth factor(IGF1)) assessment will be done as well
Read the detailed description
Most of the current strategies for bone grafting exhibit relatively unsatisfactory results and most of them are associated with drawbacks and limitations to their use and availability, and even controversial reports about their efficacy and cost-effectiveness. Furthermore, at present there are no heterologous or synthetic bone substitutes available that have superior or even the same biological or mechanical properties compared with autogenous bone graft. Therefore, there is a necessity to develop a new treatments as alternatives or adjuncts to the standard methods used for bone grafting, in an effort to overcome these limitations, which has been a goal for many decades. autogenic bone graft is widely regarded as an ideal and the best construct for grafting procedures, autogenic bone supply osteoinductive growth factors, osteogenic cells, and a structural scaffold in most cases when used to fill bone defect or treating nonunion or other indications. However, site morbidity and constraints on obtaining large quantities limit its use. in treating large bone defects resulted from bone tumors or after resection of infected bone or dead bone after trauma raise the big need for large quantity of bone graft which is most of the times difficult to take it from the patient own reservoir. so limited amount of autologous bone graft available in such cases with the superiority of the quality of autologous bone graft. Allograft on the other hand is the next best alternative; however, immunogenic rejection with the risk of disease transmission are unresolved issues. despite that ,the synthetic bone graft materials eliminate these risks, synthetic bone grafts do not transfer osteoinductive or osteogenic elements to the host site. So ,large bone defects remain a clinical challenge in autograft or allograft transplantation. using this new method of bone cultivation would like to harvest large amounts of autologous bone graft with all advantages of osteoinductive and osteogenic cells that can solve the clinical challenge in large bone defects with minimal site morbidity.
Our understanding of bone grafting at the cellular and molecular level has advanced enormously, and is still ongoing. New methods for studying this process, such as quantitative three-dimensional microcomputed tomography analyses, finite element modelling, and nanotechnology have been developed to further evaluate the mechanical properties of bone graft at the microscopic level. In addition, advances made in cellular and molecular biology have allowed detailed histological analyses, in vitro and in vivo characterization of bone-forming cells, identification of transcriptional and translational profiles of the genes and proteins involved in the process of bone grafting and fracture repair, and development of transgenic animals to explore the role of a number of genes expressed during bone repair, and their temporal and tissue-specific expression patterns . With the ongoing research in all related fields, novel therapies have been used as adjuncts or alternatives to traditional bone-grafting methods. Nevertheless, the basic concept for managing all clinical situations requiring bone grafting, particularly the complex and recalcitrant cases, remains the same, and must be applied. Treatment strategies should aim to address all (or those that require enhancement) prerequisites for optimal bone healing, including osteoconductive matrices, osteoinductive factors, osteogenic cells and mechanical stability, following the 'diamond concept' suggested for fracture healing.
The idea of using periosteal elevation to induce bone growth and cultivate new bone for grafting came after investigators noticed that a large amount of bone grows around the K-wires that investigators use to fix the iliac bone in pelvis osteotomies in the pediatric population. In fact investigators have done thousands of pelvic osteotomies( Salter Osteotomy) over the last two decades at investigators institution in royal medical services. During pelvis osteotomy, investigators elevate the periosteum and after performing the osteotomy investigators use K-wires to fix it. Usually, these K-wires are removed after the osteotomy heals by another operation. investigators always noticed that the width of the iliac bone was 3 to 4 times the original width for the same age which means that periosteal stripping can produce more bone under the periosteal tissue and the cause of change in the bone size. This raises the idea that if investigators elevate the periosteum intentionally and create a space under it by keeping it elevated using space occupying implant, the bone will grow into that space and fill it. In theory, investigators can grow new bone into that subperiosteal space. Indeed, investigators have started to test this concept and investigators have performed Bone Cultivation using a periosteal elevation technique on five patients after taking their consent who presented to us with large long bone defects and very difficult clinical scenarios that could not heal without very good quality and quantity of bone graft material.
- Conditions
- Periosteal Elevation
- Being tested
- Bone Graft Cultivation and Harvesting
- Keywords
- Bone graft, Periosteal Elevation, Cultivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Graft Cultivation and HarvestingProcedure or surgery
Participants will be randomly assigned preoperatively into three surgical groups depending on cultivation time: early-stage group, medium-stage group and late-stage group . Bone Graft Cultivation is a two-stage procedure aiming at generating new bone tissue for grafting by periosteal elevation . The first stage is the insertion of space-occupying implant which is responsible for keeping periosteal elevation for a defined time to stimulate new bone formation. The second stage is the extraction of woven bone that has been formed together with the implant.
| Study group | Role | What they receive |
|---|---|---|
| Early-Stage Group | Active comparator | 6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 6 weeks Receives: Procedure: Bone Graft Cultivation and Harvesting |
| Medium -Stage Group | Active comparator | 6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 8 weeks Receives: Procedure: Bone Graft Cultivation and Harvesting |
| Late -Stage Group | Active comparator | 6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 10 weeks Receives: Procedure: Bone Graft Cultivation and Harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of new bone
ability to generate new bone
Measured: 6-10 weeks
Secondary outcomes (1)
Assessment of Qualitative Feature of the newly formed bone
The new bone will be assessed by micro CT scan.
Measured: 6 weeks, 8 weeks , 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start19 Dec 2021
- Primary completion10 Jan 2023 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periosteal ElevationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted on 18 skeletally immature patients who are suffering Bone loss problems either posttraumatic, post-tumor resection or post-infection that requires bone grafting, attending the Pediatric orthopedic Surgery Department in king Hussein Medical center.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordanian Royal Medical Services
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Higher Education and Scientific Research, Jordan
- Responsible party
- Principal investigator, Feras Ahmed Al Ibrahim, Jordanian Royal Medical Services
- Investigators
- Feras AL Ibrahim, MD, Principal investigator, Royal Medical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270317
- Sponsor's protocol ID
- MPH/1/04/2020
- Status last verified
- Mar 2022
- First submitted
- 30 Dec 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Graft Cultivation by Periosteal Elevation
- ClinicalTrials.gov ID
- NCT05270317
- Acronym / sponsor ID
- MPH/1/04/2020
- Conditions
- Periosteal Elevation
- Keywords
- Bone graft, Periosteal Elevation, Cultivation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Jordanian Royal Medical ServicesUniversity, hospital or other
- Collaborators
- The Ministry of Higher Education and Scientific Research, Jordan
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 10 Jan 2023 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 8 Mar 2022 (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.
Bone Graft Cultivation is a two-stage procedure aiming at generating new bone tissue for grafting by periosteal elevation . The first stage is the insertion of space-occupying implant which is responsible for keeping periosteal elevation for a defined time to stimulate new bone formation. The second stage is the extraction of woven bone that has been formed together with the implant. A sufficient amount of biologically highly valuable woven bone may be produced and harvested for bone grafting using periosteal elevation method. The concept of using periosteal elevation to cultivate bone has never mentioned in orthopedic literature.
Thus, this study aims to present an original experimental Interventional (Clinical Trial) on 18 skeletally immature patients. The purpose of this non-comparative study is to test, for the first time, possibility of generating bone tissue from iliac bone and to test the bioactivity of this new "Bone Graft Material" in fillings of losses of osseous substance from various origins, such as traumatic, infection, and benign tumoral causes.
Study protocol: Participants will be randomly assigned preoperatively into three surgical groups depending on cultivation time: early-stage group, medium-stage group and late-stage group . The newly bone formed bone will undergo tissue processing, and then, bone volume/tissue volume ratio, osteoid volume/tissue volume ratio, and osteocyte count per high-power field will be analyzed. In addition to histological examination, micro-CT scanning and osteoinductive factors ( bone morphogenic protein (BMP2), Fibroblast growth factor-2(FGF2), Transforming Growth Factor(TGFB1), and Insulin-like growth factor(IGF1)) assessment will be done as well
Detailed description
Most of the current strategies for bone grafting exhibit relatively unsatisfactory results and most of them are associated with drawbacks and limitations to their use and availability, and even controversial reports about their efficacy and cost-effectiveness. Furthermore, at present there are no heterologous or synthetic bone substitutes available that have superior or even the same biological or mechanical properties compared with autogenous bone graft. Therefore, there is a necessity to develop a new treatments as alternatives or adjuncts to the standard methods used for bone grafting, in an effort to overcome these limitations, which has been a goal for many decades. autogenic bone graft is widely regarded as an ideal and the best construct for grafting procedures, autogenic bone supply osteoinductive growth factors, osteogenic cells, and a structural scaffold in most cases when used to fill bone defect or treating nonunion or other indications. However, site morbidity and constraints on obtaining large quantities limit its use. in treating large bone defects resulted from bone tumors or after resection of infected bone or dead bone after trauma raise the big need for large quantity of bone graft which is most of the times difficult to take it from the patient own reservoir. so limited amount of autologous bone graft available in such cases with the superiority of the quality of autologous bone graft. Allograft on the other hand is the next best alternative; however, immunogenic rejection with the risk of disease transmission are unresolved issues. despite that ,the synthetic bone graft materials eliminate these risks, synthetic bone grafts do not transfer osteoinductive or osteogenic elements to the host site. So ,large bone defects remain a clinical challenge in autograft or allograft transplantation. using this new method of bone cultivation would like to harvest large amounts of autologous bone graft with all advantages of osteoinductive and osteogenic cells that can solve the clinical challenge in large bone defects with minimal site morbidity.
Our understanding of bone grafting at the cellular and molecular level has advanced enormously, and is still ongoing. New methods for studying this process, such as quantitative three-dimensional microcomputed tomography analyses, finite element modelling, and nanotechnology have been developed to further evaluate the mechanical properties of bone graft at the microscopic level. In addition, advances made in cellular and molecular biology have allowed detailed histological analyses, in vitro and in vivo characterization of bone-forming cells, identification of transcriptional and translational profiles of the genes and proteins involved in the process of bone grafting and fracture repair, and development of transgenic animals to explore the role of a number of genes expressed during bone repair, and their temporal and tissue-specific expression patterns . With the ongoing research in all related fields, novel therapies have been used as adjuncts or alternatives to traditional bone-grafting methods. Nevertheless, the basic concept for managing all clinical situations requiring bone grafting, particularly the complex and recalcitrant cases, remains the same, and must be applied. Treatment strategies should aim to address all (or those that require enhancement) prerequisites for optimal bone healing, including osteoconductive matrices, osteoinductive factors, osteogenic cells and mechanical stability, following the 'diamond concept' suggested for fracture healing.
The idea of using periosteal elevation to induce bone growth and cultivate new bone for grafting came after investigators noticed that a large amount of bone grows around the K-wires that investigators use to fix the iliac bone in pelvis osteotomies in the pediatric population. In fact investigators have done thousands of pelvic osteotomies( Salter Osteotomy) over the last two decades at investigators institution in royal medical services. During pelvis osteotomy, investigators elevate the periosteum and after performing the osteotomy investigators use K-wires to fix it. Usually, these K-wires are removed after the osteotomy heals by another operation. investigators always noticed that the width of the iliac bone was 3 to 4 times the original width for the same age which means that periosteal stripping can produce more bone under the periosteal tissue and the cause of change in the bone size. This raises the idea that if investigators elevate the periosteum intentionally and create a space under it by keeping it elevated using space occupying implant, the bone will grow into that space and fill it. In theory, investigators can grow new bone into that subperiosteal space. Indeed, investigators have started to test this concept and investigators have performed Bone Cultivation using a periosteal elevation technique on five patients after taking their consent who presented to us with large long bone defects and very difficult clinical scenarios that could not heal without very good quality and quantity of bone graft material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study will be conducted on 18 skeletally immature patients who are suffering Bone loss problems either posttraumatic, post-tumor resection or post-infection that requires bone grafting, attending the Pediatric orthopedic Surgery Department in king Hussein Medical center.
| Arm | Type | Receives |
|---|---|---|
| Early-Stage Group | Active comparator | Procedure: Bone Graft Cultivation and Harvesting6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 6 weeks |
| Medium -Stage Group | Active comparator | Procedure: Bone Graft Cultivation and Harvesting6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 8 weeks |
| Late -Stage Group | Active comparator | Procedure: Bone Graft Cultivation and Harvesting6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 10 weeks |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Males or females with Bone loss pathologies.
- Males and females between one year and 14 years.
- post-traumatic, bone cysts or tumoral cases or post-infection and congenital pseudoarthrosis that requires bone grafting
Key exclusion criteria (1 listed)
- Patients with systemic illness as cardiac diseases, or mental disorders or neuromuscular disorders \& hepatic patients (generally debilitating diseases).
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 |
|---|---|---|
| Bone Graft Cultivation and HarvestingParticipants will be randomly assigned preoperatively into three surgical groups depending on cultivation time: early-stage group, medium-stage group and late-stage group . Bone Graft Cultivation is a two-stage procedure aiming at generating new bone tissue for grafting by periosteal elevation . The first stage is the insertion of space-occupying implant which is responsible for keeping periosteal elevation for a defined time to stimulate new bone formation. The second stage is the extraction of woven bone that has been formed together with the implant. | Procedure or surgery | Early-Stage Group, Late -Stage Group, Medium -Stage Group |
Primary outcome
Presence or absence of new bone
Time frame: 6-10 weeks
ability to generate new bone
1 secondary outcome
Assessment of Qualitative Feature of the newly formed bone
Time frame: 6 weeks, 8 weeks , 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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.
Feras AL Ibrahim, MD principal investigator
Royal Medical Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone Graft Cultivation and Harvesting in people with Periosteal Elevation, run by Jordanian Royal Medical Services at 1 site in Jordan.
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 1 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 21 Mar 2022. 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 Jordan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mutasem Aldhoon, MD (00962777538242, aldhoon12@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of new bone (time frame: 6-10 weeks). 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 21 Mar 2022.