Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT07066228
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-55 years old, gender unrestricted;
2. Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;
3. Solitary bone cysts involving more than 50% of the bone cross-section.
Exclusion Criteria:
1. Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;
2. Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;
3. Moderate-to-severe osteoporosis (BMD: T-score \< -2.5);
4. Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;
5. Complicated with severe brain trauma;
6. Heavy smoking, drug abuse, alcoholism, or other harmful addictions;
7. Psychiatric disorders or patients with menopausal symptoms;
8. Concurrent participation in other studies or recent completion (within 4 weeks) of other clinical trials;
9. Pregnancy, lactation, or planned pregnancy within one year after initial enrollment;
10. Psychological conditions impairing treatment compliance;
11. Congenital malformations of vital organs or other systems;
12. Nonunion caused by malignant tumor resection;
13. Refusal to accept tissue-engineered bone repair protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07066228
Study Brief:
Protocol Section:
NCT07066228