Efficacy of Bioceramic Materials for Bone Defects Repair

Clinical Study of Bioceramic Materials in Bone Defect Repair

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingqiang Yao, phD; Phone Number: 15366155699; Email: yaoqingqiang@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing First Hospital
      • Contact: yufeng Wang, Master; Phone Number: +86 15895982668; Email: wanyufeng2@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Commercial bone implant product Group; Bone repair products in the market such as artificial bones and allogeneic bones.	Device: Commercial bone implant product Group; Commercial bone implant product Group with a smooth surface （without particular microstructures）.
Experimental: 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.	Device: Mirco-structured Bioceramic Group; β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Level of bone healing	X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of nonunion	A nonunion is an arrest in the fracture repair process.	through study completion, about 12 months
Incidence of infections	If any infections happen, the experiment would be stopped.	through study completion, about 12 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: Qingqiang Yao, phD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Fractures, Bone
• Other Study ID Numbers: KY20231109-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No