NCT05270317

Bone Graft Cultivation by Periosteal Elevation

Status unknown Phase 3 Last updated 21 March 2022

What this trial tests

Phase 3 trial testing Bone Graft Cultivation and Harvesting in Periosteal Elevation in 18 participants. Status unknown.

Timeline

19 December 2021

Primary endpoint
10 January 2023

10 March 2023

Quick facts

Lead sponsor	Jordanian Royal Medical Services
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	18
Start date	19 December 2021
Primary completion	10 January 2023
Estimated completion	10 March 2023
Sites	1 location across Jordan

Drugs / interventions tested

• Bone Graft Cultivation and Harvesting

Conditions studied

• Periosteal Elevation — all drugs for Periosteal Elevation →

Sponsor

Jordanian Royal Medical Services — full company profile →

Who can join

Adults 1 to 14, any sex, with Periosteal Elevation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.