Bone Graft Cultivation by Periosteal Elevation

NCT05270317 | Unknown Phase 3 DMC

• 1 other identifier: MPH/1/04/2020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Periosteal Elevation

Keywords

Bone graft; Periosteal Elevation; Cultivation

Outcome Measures

Primary Outcomes (1)

• Presence or absence of new bone

  ability to generate new bone

  6-10 weeks

Secondary Outcomes (1)

• Assessment of Qualitative Feature of the newly formed bone

  6 weeks, 8 weeks , 10 weeks

Study Arms (3)

Early-Stage Group

ACTIVE COMPARATOR

6 patients will be allocated randomly to participate in the clinical trial with cultivation duration of 6 weeks

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

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

Procedure: Bone Graft Cultivation and Harvesting

Interventions

Bone Graft Cultivation and Harvesting PROCEDURE

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.

Early-Stage Group; Late -Stage Group; Medium -Stage Group

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with systemic illness as cardiac diseases, or mental disorders or neuromuscular disorders \& hepatic patients (generally debilitating diseases).

Sponsors & Collaborators

• Jordanian Royal Medical Services: lead
• The Ministry of Higher Education and Scientific Research, Jordan: collaborator

Study Sites (1)

Royal Medical Services

Amman, 11732, Jordan

RECRUITING

Study Officials

• Feras AL Ibrahim, MD

  Royal Medical Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mutasem Aldhoon, MD

CONTACT

00962777538242; aldhoon12@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Orthopedic Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: March 8, 2022
• Study Start: December 19, 2021
• Primary Completion: January 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)