Mg-containing Biodegradable Polymer Bone Repair Material

NCT05758623 | Unknown

• 1 other identifier: P_204970118082038
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Deformity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• to evaluate the bone graft fusion rate

  12 and 36 weeks after operation

• Improvement level of SF-36 scale and satisfaction of device operation

  at 36 weeks after operation

Study Arms (2)

magnesium containing biodegradable polymer bone repair material

PLACEBO COMPARATOR

The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd.

Device: Device

β- Tricalcium phosphate bioceramics

PLACEBO COMPARATOR

Control group application β- Tricalcium phosphate bioceramics for treatment.

Device: Device

Interventions

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.

magnesium containing biodegradable polymer bone repair material; β- Tricalcium phosphate bioceramics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd: lead
• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd

Shenzhen, Guangdong, 518105, China

RECRUITING

MeSH Terms

Interventions

Equipment and Supplies

Study Officials

• Yuxiao Lai, Professor

  Ext:+86 755 86392581 Email:Yx.Lai@siat.ac.cn Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Ling Qin, Professor

  Ext:+86-755-86392258 Email:lingqin@cuhk.edu.hk The Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Ming Zhang, MD.

CONTACT

+86 15817386880; zhangming1307@163.com

Yuxiao Meng, MD.

CONTACT

18776931278; yuxiaomeng0712@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 7, 2023
• Study Start: April 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: March 31, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-02

Locations

CN (1)