Last updated: February 24, 2023
Sponsor: Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
Overall Status: Active - Recruiting
Phase
N/A
Condition
Holoprosencephaly
Birth Defects
Treatment
N/AClinical Study ID
NCT05758623
P_204970118082038
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years old and ≤ 75 years old, regardless of gender;
- Bone defect exists in one of the following anatomical positions, and bone grafting isrequired: Upper limb bones: humerus, ulna, radius, metacarpus, carpus, phalanges; Lower limb bones: femur, tibia, fibula, calcaneus, navicular bone, wedge bone, cuboidbone, metatarsal bone, talus and phalanges;
- The maximum diameter of the expected or actual three-dimensional bone defect is ≥ 0.5cm and ≤ 6cm, and the defect is only one;
- The bone defect site is expected to be fixed with non-degradable internal fixationsystem during operation;
- Subjects or their legal representatives can understand the purpose of the study andshow sufficient compliance with the study protocol and sign the informed consent form.
Exclusion
Exclusion Criteria:
- The blood glucose control is unstable and cannot meet the operation conditions;
- Severe coagulation dysfunction (PT or APTT ≥ 2 times the upper limit of normal value);
- History of arterial thrombosis attack (such as stroke, angina pectoris, acutemyocardial infarction, etc.) or NYHA grade ≥ III within 3 months before enrollment;
- Oral or injection of sedative and hypnotic drugs or non-steroidal anti-inflammatorydrugs (except aspirin) every week within 3 months before enrollment;
- He had received chemotherapy drugs or radiotherapy within 3 months before admission;
- Cumulative oral or injection of corticosteroids or various growth factors for ≥ 14days within 1 month before enrollment;
- Suffering from systemic infection or uncontrollable local infection, serious softtissue injury at the proposed operation site, serious vascular or nerve injury,malignant tumor, confirmed severe malnutrition or other important organ failure;
- The limb to be operated on has osteofascial compartment syndrome;
- Structural bone grafting is required;
- Pregnant or lactating women;
- Participate in clinical trials of other drugs or medical devices within one monthbefore enrollment;
- For the benefit of the subject, the researcher believes that it should not participatein other situations of this clinical trial.
Study Design
Total Participants: 176
Study Start date:
April 01, 2021
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
Shenzhen, Guangdong 518105
ChinaActive - Recruiting

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