Bone DeformityNCT05758623
Mg-containing Biodegradable Polymer Bone Repair Material
A study testing Device in people with Bone Deformity, run by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd at 1 site in China.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Deformity
- What is being tested?
- Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
Shenzhen, Guangdong, 518105
Ming Zhang, MD., 15817386880, zhangming1307@163.com
About this study
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.
Read the 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.
- Conditions
- Bone Deformity
- Being tested
- Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Device |
| β- Tricalcium phosphate bioceramics | Placebo comparator | Control group application β- Tricalcium phosphate bioceramics for treatment. Receives: Device: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks after standard operation
Secondary outcomes (2)
to evaluate the bone graft fusion rate
to evaluate the bone graft fusion rate at 12 and 36 weeks after operation
Measured: 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
Measured: at 36 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Apr 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Yuxiao Lai, Professor, Principal investigator, Ext:+86 755 86392581 Email:Yx.Lai@siat.ac.cn Shenzhen Institute of Advanced Technology, Chinese Academy of SciencesLing Qin, Professor, Study director, Ext:+86-755-86392258 Email:lingqin@cuhk.edu.hk The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758623
- Sponsor's protocol ID
- P_204970118082038
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mg-containing Biodegradable Polymer Bone Repair Material
- ClinicalTrials.gov ID
- NCT05758623
- Acronym / sponsor ID
- P_204970118082038
- Conditions
- Bone Deformity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Shenzhen Zhongke Jingcheng Medical Technology Co., LtdUniversity, hospital or other
- Collaborators
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Chinese University of Hong Kong
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium containing biodegradable polymer bone repair material | Placebo comparator | Device: DeviceThe experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. |
| β- Tricalcium phosphate bioceramics | Placebo comparator | Device: DeviceControl group application β- Tricalcium phosphate bioceramics for treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeviceThe 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. | Device | magnesium containing biodegradable polymer bone repair material, β- Tricalcium phosphate bioceramics |
Primary outcome
Bone graft fusion rate
Time frame: 24 weeks after standard operation
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
2 secondary outcomes
to evaluate the bone graft fusion rate
Time frame: 12 and 36 weeks after operation
Improvement level of SF-36 scale and satisfaction of device operation
Time frame: at 36 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxiao Lai, Professor principal investigator
Ext:+86 755 86392581 Email:Yx.Lai@siat.ac.cn Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Ling Qin, Professor study director
Ext:+86-755-86392258 Email:lingqin@cuhk.edu.hk The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device in people with Bone Deformity, run by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhang, MD. (+86 15817386880 ext. 0755 23729746, zhangming1307@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone graft fusion rate (time frame: 24 weeks after standard operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.