Efficacy of Bioceramic Materials for Bone Defects Repair

NCT06249906 | Recruiting

• 1 other identifier: KY20231109-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain self-efficacy (PSEQ)

  through study completion, about 12 months

• Incidence of nonunion

  through study completion, about 12 months

• Incidence of infections

  through study completion, about 12 months

Study Arms (2)

Commercial bone implant product Group

ACTIVE COMPARATOR

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

Device: Commercial bone implant product Group

Mirco-structured Bioceramic Group

EXPERIMENTAL

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

Interventions

Commercial bone implant product Group DEVICE

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

Commercial bone implant product Group

Mirco-structured Bioceramic Group DEVICE

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

Mirco-structured Bioceramic Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily take the test and sign the informed consent form;
• Patients aged 18-65 years old with no history of allergies;
• Patients able to communicate well with the investigator and follow the requirements of the entire trial.

You may not qualify if:

• Patients who refuse to sign the informed consent form to participate in the trial;
• Patients who are not in the age range of 18 to 65 years;
• 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;
• Patients in the acute phase of local or systemic bacterial infections;
• Patients who cannot cooperate with the operation and evaluate the effect;
• Other conditions that are considered inappropriate by the investigator to participate in the study.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Qingqiang Yao, phD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Qingqiang Yao, phD

CONTACT

15366155699; yaoqingqiang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: February 8, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 12, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)