Mg-containing Biodegradable Polymer Bone Repair Material

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/A

Clinical Study ID

NCT05758623
P_204970118082038
  • Ages 18-75
  • All Genders

Study Summary

The subjects of this study are patients with non-load-bearing bone defects of the extremities who need bone grafting surgery. The patients was treated with bone graft using magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd.. Three follow-up visits were performed at the 12th, 24th and 36th weeks after bone grafting, the clinical role for bone will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old and ≤ 75 years old, regardless of gender;
  2. 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;
  3. The maximum diameter of the expected or actual three-dimensional bone defect is ≥ 0.5cm and ≤ 6cm, and the defect is only one;
  4. The bone defect site is expected to be fixed with non-degradable internal fixationsystem during operation;
  5. 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:

  1. The blood glucose control is unstable and cannot meet the operation conditions;
  2. Severe coagulation dysfunction (PT or APTT ≥ 2 times the upper limit of normal value);
  3. History of arterial thrombosis attack (such as stroke, angina pectoris, acutemyocardial infarction, etc.) or NYHA grade ≥ III within 3 months before enrollment;
  4. Oral or injection of sedative and hypnotic drugs or non-steroidal anti-inflammatorydrugs (except aspirin) every week within 3 months before enrollment;
  5. He had received chemotherapy drugs or radiotherapy within 3 months before admission;
  6. Cumulative oral or injection of corticosteroids or various growth factors for ≥ 14days within 1 month before enrollment;
  7. 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;
  8. The limb to be operated on has osteofascial compartment syndrome;
  9. Structural bone grafting is required;
  10. Pregnant or lactating women;
  11. Participate in clinical trials of other drugs or medical devices within one monthbefore enrollment;
  12. 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

The subjects of this study are patients with non-load-bearing bone defects of the extremities who need bone grafting surgery. The subjects were randomly divided into experimental group and control group. The experimental group was treated with bone graft using magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd., while the control group was treated with bone graft β- Tricalcium phosphate bioceramics were used for bone transplantation. Three follow-up visits were performed at the 12th, 24th and 36th weeks after bone grafting. It is estimated that 176 cases will be recruited in total, and 135 cases have been recruited since April 2021. This product can be degraded and absorbed in vivo, and it can promote the formation of new bone.

Connect with a study center

  • Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd

    Shenzhen, Guangdong 518105
    China

    Active - Recruiting

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