Bone Defects of the LimbsNCT06959459
Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities
A study testing Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC. in people with Bone Defects of the Limbs, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Defects of the Limbs
- What is being tested?
- Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years old and ≤ 60 years old, regardless of sex;
- Cavitary bone defects in the limbs requiring bone grafting treatment;
- Bone defect volume ≥ 1 cm³ and ≤ 8 cm³, with only one bone defect requiring intervention;
- Subjects or their legal guardians can understand the study objectives, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
Who cannot join
- Open fractures with wound contamination;
- Repair of infectious bone defects;
- Structural bone grafting required at the defect site;
- Osteofascial compartment syndrome in the affected limb scheduled for surgery;
- Presence of systemic infection, uncontrolled local infection at the surgical site, malignant tumor (including metastatic tumors) at the defect site, osteonecrosis at the defect site, severe nerve/soft tissue/vascular injury at the defect site, confirmed severe malnutrition, or dysfunction/failure of other vital organs;
- Calcium and phosphorus metabolic abnormalities (calcium/phosphorus levels > 1.5 times the upper limit of normal values);
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- History of diabetes with fasting blood glucose ≥ 6.1 mmol/L;
- Coagulation dysfunction (prothrombin time [PT] or activated partial thromboplastin time [APTT] > 2 times the upper limit of normal values);
- Use of chemotherapeutic agents or receipt of radiotherapy within 3 months prior to enrollment;
- Cumulative use of corticosteroids or growth factors for ≥ 14 days within 1 month prior to enrollment;
- Long-term use of sedative-hypnotic drugs (continuous use for > 3 months) or non-steroidal anti-inflammatory drugs (NSAIDs, continuous use for > 3 months);
- Known allergy to bovine-derived materials or collagen products;
- Pregnant or lactating females;
- Participation in other interventional clinical trials for drugs or medical devices within 1 month prior to enrollment;
- Any other conditions where investigators, in their professional judgment, deem the subject ineligible to participate in the trial for the subject's safety or benefit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hosptial
Beijing
Meng Li, limeng1@301.hospital.com.cn
About this study
Official title: Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial
Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial
- Conditions
- Bone Defects of the Limbs
- Being tested
- Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC., Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.Device
Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.
Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.Device
Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC. Receives: Device: Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC. |
| Control group | Active comparator | Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd. Receives: Device: Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone graft fusion rate
Measured: 24weeks after surgery
Secondary outcomes (3)
Bone defect healing rate
Measured: 4 and 12 weeks after surgery
New bone formation rate
Measured: 4, 12 and 24 weeks after surgery
SF-36 scale
Measured: 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start10 May 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Defects of the LimbsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959459
- Sponsor's protocol ID
- 2024QX008-KS002
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06959459
- Acronym / sponsor ID
- 2024QX008-KS002
- Conditions
- Bone Defects of the Limbs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 May 2025 (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.
Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC. |
| Control group | Active comparator | Device: Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old and ≤ 60 years old, regardless of sex;
- Cavitary bone defects in the limbs requiring bone grafting treatment;
- Bone defect volume ≥ 1 cm³ and ≤ 8 cm³, with only one bone defect requiring intervention;
- Subjects or their legal guardians can understand the study objectives, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
Key exclusion criteria (15 listed)
- Open fractures with wound contamination;
- Repair of infectious bone defects;
- Structural bone grafting required at the defect site;
- Osteofascial compartment syndrome in the affected limb scheduled for surgery;
- Presence of systemic infection, uncontrolled local infection at the surgical site, malignant tumor (including metastatic tumors) at the defect site, osteonecrosis at the defect site, severe nerve/soft tissue/vascular injury at the defect site, confirmed severe malnutrition, or dysfunction/failure of other vital organs;
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 |
|---|---|---|
| Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC. | Device | Intervention Group |
| Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd. | Device | Control group |
Primary outcome
Bone graft fusion rate
Time frame: 24weeks after surgery
3 secondary outcomes
Bone defect healing rate
Time frame: 4 and 12 weeks after surgery
New bone formation rate
Time frame: 4, 12 and 24 weeks after surgery
SF-36 scale
Time frame: 24 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC. in people with Bone Defects of the Limbs, run by Chinese PLA General Hospital 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 4 inclusion and 15 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: opening soon, as of the sponsor's last update on 6 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhang (+86 15334508850, bszw@hotmail.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: 24weeks after surgery). 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 6 May 2025.