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NCT Number: NCT06249906

Efficacy of Bioceramic Materials for Bone Defects 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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Commercial bone implant product Group

Device

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

Mirco-structured Bioceramic Group

Device

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

Primary outcomes

  1. Quality of life (SF-36)

    Time frame: 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.

  2. Level of bone healing

    Time frame: 12 months

    X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.

Other outcomes

  1. Pain self-efficacy (PSEQ)

    Time frame: through study completion, about 12 months

    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.

  2. Incidence of nonunion

    Time frame: through study completion, about 12 months

    A nonunion is an arrest in the fracture repair process.

  3. Incidence of infections

    Time frame: through study completion, about 12 months

    If any infections happen, the experiment would be stopped.

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqiang Yao, phD

CONTACT

[email protected]

15366155699

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Clinical Study of Bioceramic Materials in Bone Defect Repair

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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