Efficacy of Bioceramic Materials for Bone Defects Repair

Osteo Arthritis Knee Clinical Trial

Official title:

Clinical Study of Bioceramic Materials in Bone Defect Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249906
• Other study ID #: KY20231109-04
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: November 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Qingqiang Yao, phD
• Phone: 15366155699
• Email: yaoqingqiang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Fracture
• Bone Injury
• Bone Lesion
• Bone Loss
• Cartilage Degeneration
• Fractures, Bone
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Commercial bone implant product Group
Commercial bone implant product Group with a smooth surface (without particular microstructures).
• Mirco-structured Bioceramic Group
ß-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain self-efficacy (PSEQ)	The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire, developed in the 1980s by Michael Nicholas to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentations.	through study completion, about 12 months
Other	Incidence of nonunion	A nonunion is an arrest in the fracture repair process.	through study completion, about 12 months
Other	Incidence of infections	If any infections happen, the experiment would be stopped.	through study completion, about 12 months
Primary	Quality of life (SF-36)	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.	12 months
Primary	Level of bone healing	X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.	12 months