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Mg-containing Biodegradable Polymer Bone Repair Material

Primary Purpose

Bone Deformity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Device
Sponsored by
Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Deformity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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; 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 fixation system during operation; 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: 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, acute myocardial infarction, etc.) or NYHA grade ≥ III within 3 months before enrollment; Oral or injection of sedative and hypnotic drugs or non-steroidal anti-inflammatory drugs (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 ≥ 14 days within 1 month before enrollment; 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; 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 month before enrollment; For the benefit of the subject, the researcher believes that it should not participate in other situations of this clinical trial.

Sites / Locations

  • Shenzhen Zhongke Jingcheng Medical Technology Co., LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

magnesium containing biodegradable polymer bone repair material

β- Tricalcium phosphate bioceramics

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

to evaluate the bone graft fusion rate
to evaluate the bone graft fusion rate at 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

Full Information

First Posted
February 13, 2023
Last Updated
February 24, 2023
Sponsor
Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
Collaborators
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05758623
Brief Title
Mg-containing Biodegradable Polymer Bone Repair Material
Official Title
Mg-containing Biodegradable Polymer Bone Repair Material
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
Collaborators
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Deformity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnesium containing biodegradable polymer bone repair material
Arm Type
Placebo Comparator
Arm Description
The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd.
Arm Title
β- Tricalcium phosphate bioceramics
Arm Type
Placebo Comparator
Arm Description
Control group application β- Tricalcium phosphate bioceramics for treatment.
Intervention Type
Device
Intervention Name(s)
Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone graft fusion rate
Description
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
Time Frame
24 weeks after standard operation
Secondary Outcome Measure Information:
Title
to evaluate the bone graft fusion rate
Description
to evaluate the bone graft fusion rate at 12 and 36 weeks after operation
Time Frame
12 and 36 weeks after operation
Title
Improvement level of SF-36 scale and satisfaction of device operation
Description
Improvement level of SF-36 scale and satisfaction of instrument operation at 36 weeks after operation
Time Frame
at 36 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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; 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 fixation system during operation; 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: 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, acute myocardial infarction, etc.) or NYHA grade ≥ III within 3 months before enrollment; Oral or injection of sedative and hypnotic drugs or non-steroidal anti-inflammatory drugs (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 ≥ 14 days within 1 month before enrollment; 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; 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 month before enrollment; For the benefit of the subject, the researcher believes that it should not participate in other situations of this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Zhang, MD.
Phone
+86 15817386880
Ext
0755 23729746
Email
zhangming1307@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxiao Meng, MD.
Phone
18776931278
Email
yuxiaomeng0712@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuxiao Lai, Professor
Organizational Affiliation
Ext:+86 755 86392581 Email:Yx.Lai@siat.ac.cn Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ling Qin, Professor
Organizational Affiliation
Ext:+86-755-86392258 Email:lingqin@cuhk.edu.hk The Chinese University of Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518105
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Zhang, MD.
Phone
15817386880
Email
zhangming1307@163.com

12. IPD Sharing Statement

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Mg-containing Biodegradable Polymer Bone Repair Material

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