Efficacy of Bioceramic Materials for Bone Defects Repair

Not Applicable

Recruiting

• Conditions: Osteo Arthritis Knee; Bone Lesion; Bone Loss; Cartilage Degeneration; Bone Fracture; Bone Injury
• Interventions: Device: Commercial bone implant product Group; Device: Mirco-structured Bioceramic Group

• Registration Number: NCT06249906
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Start: 2024-02-20
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercial bone implant product Group	Commercial bone implant product Group	Bone repair products in the market such as artificial bones and allogeneic bones.
Mirco-structured Bioceramic Group	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.

Primary Outcome Measures

Name	Time	Method
Quality of life (SF-36)	12 months	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Level of bone healing	12 months	X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China