Mg-containing Biodegradable Polymer Bone Repair Material

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Deformity
• Intervention / Treatment: Device: Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Zhang, MD.; Phone Number: 0755 23729746 +86 15817386880; Email: zhangming1307@163.com
• Study Contact Backup: Name: Yuxiao Meng, MD.; Phone Number: 18776931278; Email: yuxiaomeng0712@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518105
      • Recruiting
      • Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
      • Contact: Ming Zhang, MD.; Phone Number: 15817386880; Email: zhangming1307@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 is required:

   Upper limb bones: humerus, ulna, radius, metacarpus, carpus, phalanges;

   Lower limb bones: femur, tibia, fibula, calcaneus, navicular bone, wedge bone, cuboid bone, 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 fixation system during operation;
5. Subjects or their legal representatives can understand the purpose of the study and show sufficient compliance with the study protocol and sign the informed consent form.

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, acute myocardial infarction, etc.) or NYHA grade ≥ III within 3 months before enrollment;
4. Oral or injection of sedative and hypnotic drugs or non-steroidal anti-inflammatory drugs (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 ≥ 14 days within 1 month before enrollment;
7. Suffering from systemic infection or uncontrollable local infection, serious soft tissue 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 month before enrollment;
12. For the benefit of the subject, the researcher believes that it should not participate in other situations of this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: magnesium containing biodegradable polymer bone repair material; The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd.	Device: Device; The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. Control group application β- Tricalcium phosphate bioceramics for treatment.
Placebo Comparator: β- Tricalcium phosphate bioceramics; Control group application β- Tricalcium phosphate bioceramics for treatment.	Device: Device; The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. Control group application β- Tricalcium phosphate bioceramics for treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone graft fusion rate	When Mg-containing degradable polymer bone repair material is used to repair non-load-bearing bone defects of limbs, the main effective evaluation index is bone graft fusion rate at 24 weeks after operation	24 weeks after standard operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate the bone graft fusion rate	to evaluate the bone graft fusion rate at 12 and 36 weeks after operation	12 and 36 weeks after operation
Improvement level of SF-36 scale and satisfaction of device operation	Improvement level of SF-36 scale and satisfaction of instrument operation at 36 weeks after operation	at 36 weeks after operation

Collaborators and Investigators

• Sponsor: Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
• Collaborators: Chinese University of Hong Kong; Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
• Investigators: Principal Investigator: Yuxiao Lai, Professor, Ext:+86 755 86392581 Email:Yx.Lai@siat.ac.cn Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences; Study Director: Ling Qin, Professor, Ext:+86-755-86392258 Email:lingqin@cuhk.edu.hk The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Estimate): March 7, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: P_204970118082038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No