Efficacy of Bioceramic Materials for Bone Defects Repair

NCT ID: NCT06249906

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2026-12-30

Brief Summary

The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Detailed Description

The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Conditions

Bone Lesion; Cartilage Degeneration; Osteo Arthritis Knee; Bone Fracture; Bone Injury; Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Commercial bone implant product Group

Bone repair products in the market such as artificial bones and allogeneic bones.

Group Type: ACTIVE_COMPARATOR

Commercial bone implant product Group

Intervention Type: DEVICE

Commercial bone implant product Group with a smooth surface （without particular microstructures）.

Mirco-structured Bioceramic Group

β-Tricalcium phosphate (β-TCP) is a material with excellent biocompatibility and osteoinduction and bone guidance properties, which can provide mechanical strength equal to or better than that of human cancellous bone.

Group Type: EXPERIMENTAL

Mirco-structured Bioceramic Group

Intervention Type: DEVICE

β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.

Interventions

Commercial bone implant product Group

Commercial bone implant product Group with a smooth surface （without particular microstructures）.

Intervention Type: DEVICE

Mirco-structured Bioceramic Group

β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients who voluntarily take the test and sign the informed consent form;

2. Patients aged 18-65 years old with no history of allergies;

3. Patients able to communicate well with the investigator and follow the requirements of the entire trial.

Exclusion Criteria

1. Patients who refuse to sign the informed consent form to participate in the trial;

2. Patients who are not in the age range of 18 to 65 years;

3. Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;

4. Patients in the acute phase of local or systemic bacterial infections;

5. Patients who cannot cooperate with the operation and evaluate the effect;

6. Other conditions that are considered inappropriate by the investigator to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qingqiang Yao, phD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingqiang Yao, phD

Role: CONTACT

yaoqingqiang@126.com

15366155699

Facility Contacts

yufeng Wang, Master

Role: primary

wanyufeng2@126.com

+86 15895982668

Other Identifiers

KY20231109-04

Identifier Type: -

Identifier Source: org_study_id