Efficacy of Bioceramic Materials for Bone Defects Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanjing First Hospital, Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Commercial bone implant product Group
DeviceCommercial bone implant product Group with a smooth surface （without particular microstructures）.
Mirco-structured Bioceramic Group
Deviceβ-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Commercial bone implant product GroupActive comparator 1 intervention
Group B: Mirco-structured Bioceramic GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
Level of bone healing
X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.
Time frame
12 monthsOther outcomes
1
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.
Time frame
through study completion, about 12 months2
Incidence of nonunion
A nonunion is an arrest in the fracture repair process.
Time frame
through study completion, about 12 months3
Incidence of infections
If any infections happen, the experiment would be stopped.
Time frame
through study completion, about 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov