Bone DefectMAGBONENCT07794202
Clinical Efficacy Study of Magnesium-Containing Degradable Polymer Bone Repair Material for Bone-Defect Repair After Extremity Bone Tumor Resection
A study testing Magnesium-containing degradable polymer bone repair material and Conventional non-magnesium bone repair material in people with Bone Defect and Bone Tumor of Extremity, run by Yu Zhang, PhD at 1 site in China.
Trial summary
This is a single-center prospective randomized open-label non-inferiority clinical trial for adult patients with bone defects after extremity bone tumor resection. This study aims to evaluate the analgesic effect, osteogenic capacity and safety of magnesium-containing degradable polymer bone repair material. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Defect, Bone Tumor of Extremity, Bone-Like Tumor Lesion
- What is being tested?
- Magnesium-containing degradable polymer bone repair material and Conventional non-magnesium bone repair material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Jun 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with bone tumors (benign or borderline) or tumor-like bone lesions of extremities confirmed by imaging and/or pathology, scheduled for surgical resection.
- Bone defects formed after resection of extremity bone tumor, requiring artificial bone repair material for defect filling and reconstruction.
- Age from 18 to 75 years old, regardless of gender.
- Good general preoperative condition and able to tolerate surgical treatment.
- Voluntarily participate in this study, provide written informed consent, and be judged by investigators to comply with study protocol and complete follow-up visits.
- No postoperative local rejection or allergic reaction at the operative site.
- Diameter of bone defect ≤ 6 cm, and product usage volume ≤ 77 cm³.
- Bone defect located in upper extremity (humerus, ulna-radius, carpal bones) or lower extremity (femur, tibia, fibula, ankle, foot bones).
Who cannot join
- Active local infection at operative site or severe systemic infection.
- Severe bone metabolic diseases that may interfere with bone healing, such as severe osteoporosis or uncontrolled hyperparathyroidism.
- Severe cardiac, hepatic, renal insufficiency or other serious systemic diseases which cannot tolerate surgery or interfere with study evaluation.
- Severe hematological or immune system disorders.
- Pregnant or lactating women.
- Expected survival less than 12 months, or unable to complete at least 12-month follow-up.
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- Known or suspected allergy to collagen, hydroxyapatite or other components of bone repair materials.
- Occurrence of local rejection or allergic reaction at operative site after surgery.
- Diameter of bone defect > 6 cm, or product usage volume > 77 cm³.
- Any other conditions judged by investigators making the subject unsuitable for enrollment.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yu Zhang,Director of Department of Orthopedic Oncology, +8613602744495, luck_2001@126.com
About this study
Official title: Clinical Study on the Efficacy of Magnesium-Containing Degradable Polymer Bone Repair Material for Repairing Bone Defects After Extremity Bone Tumor Resection
This is a single-center prospective randomized open-label non-inferiority clinical trial for adult patients with bone defects after extremity bone tumor resection. This study aims to evaluate the analgesic effect, osteogenic capacity and safety of magnesium-containing degradable polymer bone repair material.
Up to 72 eligible patients aged 18-75 years will be enrolled and randomly divided into two groups at a 1:1 ratio. Patients in the experimental group will receive magnesium-containing degradable polymer bone repair material to fill bone defects after tumor removal. Patients in the control group will be implanted with conventional magnesium-free bone repair material. All participants will receive unified surgical anti-infection treatment, pain control, wound management and postoperative rehabilitation.The main study goal is to test whether the pain-relieving effect of the magnesium-containing material is not worse than conventional bone repair material. We will calculate total opioid pain-killer medicine consumption within 3 days, 7 days and 1 month after surgery. Secondary observations include newly-formed bone volume measured by CT three-dimensional reconstruction, surgical site infection rate and local tumor recurrence rate. Patients will complete scheduled follow-up visits at 1-month, 3-month and 6-month after surgery. All unexpected health problems or adverse reactions will be recorded during follow-up.
Read the detailed description
This investigator-initiated single-center prospective randomized open-label non-inferiority trial plans to recruit 72 adult subjects with bone defects following extremity bone tumor or tumor-like lesion resection. Randomization will be stratified by upper-limb versus lower-limb defect location to balance mechanical load confounding between groups, with 36 subjects allocated to each arm.
After standard tumor resection, the experimental group receives implantation of magnesium-containing degradable polymer bone repair material. The control group uses commercially available conventional bone repair material without magnesium. Post-operative standardized care protocols including antibiotic prophylaxis, stepwise analgesia regimen, wound dressing and weight-bearing rehabilitation are identical for both groups. Opioid consumption will be converted to morphine-equivalent dose for primary endpoint analysis, with a pre-specified non-inferiority margin of 9.726 mg morphine equivalent. At 1-, 3- and 6-month follow-ups, thin-slice CT scans are performed for quantitative 3D reconstruction to assess new bone formation volume. Two independent radiology reviewers blinded to group assignment conduct volumetric measurement to reduce assessment bias. Surgical-site infection is defined by combined clinical manifestation, laboratory tests and bacterial culture results. Local tumor recurrence is confirmed by imaging or pathological biopsy. Safety assessments cover material-related adverse reactions, implant-associated complications and surgery-related adverse events.Statistical analyses will test non-inferiority for the primary endpoint. Continuous secondary outcomes will be analyzed using t-test or rank-sum test; categorical variables will adopt Chi-square test or Fisher's exact test. Subgroup analyses for upper-limb and lower-limb subgroups will be performed. Both full-analysis set and per-protocol set will be used for efficacy assessment. This trial follows the Declaration of Helsinki and has obtained institutional ethics committee approval. Written informed consent will be obtained from each participant before enrolment.
- Conditions
- Bone Defect, Bone Tumor of Extremity, Bone-Like Tumor Lesion
- Being tested
- Magnesium-containing degradable polymer bone repair material, Conventional non-magnesium bone repair material
- Keywords
- Magnesium-containing degradable polymer bone repair material, Extremity bone tumor resection, Bone regeneration, Post-operative analgesia, Non-inferiority clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-containing degradable polymer bone repair materialDevice
Implanted magnesium-containing degradable polymer bone repair material for bone defect reconstruction
Conventional non-magnesium bone repair materialDevice
Implanted conventional non-magnesium bone repair material for bone defect reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Magnesium-containing degradable polymer bone repair material implantation | Experimental | Patients receive implantation of magnesium-containing degradable polymer bone repair material for bone defect repair Receives: Device: Magnesium-containing degradable polymer bone repair material |
| Control group: Conventional bone repair material implantation | Active comparator | Patients receive implantation of conventional bone repair material for bone defect repair Receives: Device: Conventional non-magnesium bone repair material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative dose of tramadol within 12-week post-operation
Total cumulative dosage of tramadol (mg) used for postoperative pain control within 12 weeks after surgical implantation of bone repair material
Measured: 12 weeks after surgical implantation
Secondary outcomes (3)
Surgical site infection (SSI) rate
Proportion of participants presenting surgical site infection within 12-week post-operation, assessed by clinical signs and laboratory examinations.
Measured: 12 weeks after surgical implantation
Local tumor recurrence rate
Proportion of participants with local tumor recurrence confirmed by imaging examination.
Measured: 24 weeks after surgical implantation
New bone volume assessed by CT three-dimensional reconstruction
Quantitative new bone volume within bone defect area measured by postoperative CT three-dimensional reconstruction.
Measured: 24 weeks after surgical implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectStudies 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
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Zhang, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Zhang, PhD, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794202
- Sponsor's protocol ID
- KY2026-618-02
- Acronym
- MAGBONE
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy of Magnesium-Containing Degradable Polymer Bone Repair Material for Repairing Bone Defects After Extremity Bone Tumor Resection
- ClinicalTrials.gov ID
- NCT07794202
- Acronym / sponsor ID
- MAGBONE / KY2026-618-02
- Conditions
- Bone Defect, Bone Tumor of Extremity, Bone-Like Tumor Lesion
- Keywords
- Magnesium-containing degradable polymer bone repair material, Extremity bone tumor resection, Bone regeneration, Post-operative analgesia, Non-inferiority clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Yu Zhang, PhDUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 31 Aug 2026 (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.
This is a single-center prospective randomized open-label non-inferiority clinical trial for adult patients with bone defects after extremity bone tumor resection. This study aims to evaluate the analgesic effect, osteogenic capacity and safety of magnesium-containing degradable polymer bone repair material.
Up to 72 eligible patients aged 18-75 years will be enrolled and randomly divided into two groups at a 1:1 ratio. Patients in the experimental group will receive magnesium-containing degradable polymer bone repair material to fill bone defects after tumor removal. Patients in the control group will be implanted with conventional magnesium-free bone repair material. All participants will receive unified surgical anti-infection treatment, pain control, wound management and postoperative rehabilitation.The main study goal is to test whether the pain-relieving effect of the magnesium-containing material is not worse than conventional bone repair material. We will calculate total opioid pain-killer medicine consumption within 3 days, 7 days and 1 month after surgery. Secondary observations include newly-formed bone volume measured by CT three-dimensional reconstruction, surgical site infection rate and local tumor recurrence rate. Patients will complete scheduled follow-up visits at 1-month, 3-month and 6-month after surgery. All unexpected health problems or adverse reactions will be recorded during follow-up.
Detailed description
This investigator-initiated single-center prospective randomized open-label non-inferiority trial plans to recruit 72 adult subjects with bone defects following extremity bone tumor or tumor-like lesion resection. Randomization will be stratified by upper-limb versus lower-limb defect location to balance mechanical load confounding between groups, with 36 subjects allocated to each arm.
After standard tumor resection, the experimental group receives implantation of magnesium-containing degradable polymer bone repair material. The control group uses commercially available conventional bone repair material without magnesium. Post-operative standardized care protocols including antibiotic prophylaxis, stepwise analgesia regimen, wound dressing and weight-bearing rehabilitation are identical for both groups. Opioid consumption will be converted to morphine-equivalent dose for primary endpoint analysis, with a pre-specified non-inferiority margin of 9.726 mg morphine equivalent. At 1-, 3- and 6-month follow-ups, thin-slice CT scans are performed for quantitative 3D reconstruction to assess new bone formation volume. Two independent radiology reviewers blinded to group assignment conduct volumetric measurement to reduce assessment bias. Surgical-site infection is defined by combined clinical manifestation, laboratory tests and bacterial culture results. Local tumor recurrence is confirmed by imaging or pathological biopsy. Safety assessments cover material-related adverse reactions, implant-associated complications and surgery-related adverse events.Statistical analyses will test non-inferiority for the primary endpoint. Continuous secondary outcomes will be analyzed using t-test or rank-sum test; categorical variables will adopt Chi-square test or Fisher's exact test. Subgroup analyses for upper-limb and lower-limb subgroups will be performed. Both full-analysis set and per-protocol set will be used for efficacy assessment. This trial follows the Declaration of Helsinki and has obtained institutional ethics committee approval. Written informed consent will be obtained from each participant before enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Magnesium-containing degradable polymer bone repair material implantation | Experimental | Device: Magnesium-containing degradable polymer bone repair materialPatients receive implantation of magnesium-containing degradable polymer bone repair material for bone defect repair |
| Control group: Conventional bone repair material implantation | Active comparator | Device: Conventional non-magnesium bone repair materialPatients receive implantation of conventional bone repair material for bone defect repair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with bone tumors (benign or borderline) or tumor-like bone lesions of extremities confirmed by imaging and/or pathology, scheduled for surgical resection.
- Bone defects formed after resection of extremity bone tumor, requiring artificial bone repair material for defect filling and reconstruction.
- Age from 18 to 75 years old, regardless of gender.
- Good general preoperative condition and able to tolerate surgical treatment.
- Voluntarily participate in this study, provide written informed consent, and be judged by investigators to comply with study protocol and complete follow-up visits.
Key exclusion criteria (10 listed)
- Active local infection at operative site or severe systemic infection.
- Severe bone metabolic diseases that may interfere with bone healing, such as severe osteoporosis or uncontrolled hyperparathyroidism.
- Severe cardiac, hepatic, renal insufficiency or other serious systemic diseases which cannot tolerate surgery or interfere with study evaluation.
- Severe hematological or immune system disorders.
- Pregnant or lactating women.
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 |
|---|---|---|
| Magnesium-containing degradable polymer bone repair materialImplanted magnesium-containing degradable polymer bone repair material for bone defect reconstruction | Device | Magnesium-containing degradable polymer bone repair material implantation |
| Conventional non-magnesium bone repair materialImplanted conventional non-magnesium bone repair material for bone defect reconstruction | Device | Control group: Conventional bone repair material implantation |
Primary outcome
Total cumulative dose of tramadol within 12-week post-operation
Time frame: 12 weeks after surgical implantation
Total cumulative dosage of tramadol (mg) used for postoperative pain control within 12 weeks after surgical implantation of bone repair material
3 secondary outcomes
Surgical site infection (SSI) rate
Time frame: 12 weeks after surgical implantation
Local tumor recurrence rate
Time frame: 24 weeks after surgical implantation
New bone volume assessed by CT three-dimensional reconstruction
Time frame: 24 weeks after surgical implantation
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 31 Aug 2026.
- 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 Magnesium-containing degradable polymer bone repair material and Conventional non-magnesium bone repair material in people with Bone Defect and Bone Tumor of Extremity, run by Yu Zhang, PhD 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 8 inclusion and 10 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 31 Aug 2026. 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 Yu Zhang,Director of Department of Orthopedic Oncology (+8613602744495, luck_2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cumulative dose of tramadol within 12-week post-operation (time frame: 12 weeks after surgical implantation). 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 31 Aug 2026.