Bone DefectsNCT06269354
Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology
An observational study of Bone Defects, run by Peking University Third Hospital at 1 site in China.
Trial summary
The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone Defects
- What is being tested?
- 3D printed prostheses
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lower limb defects
Who may be able to join
- Patients with traumatic lower limb bone defect;
- Infected lower limb bone defect patients;
- Patients with neoplastic lower limb bone defect;
- The above reasons caused bone defects of more than 5CM
- at least 18 years of age;
- Sign an informed agreement and join the study cohort voluntarily.
Who cannot join
- Patients who do not agree to the use of 3D printed microporous titanium alloy prostheses;
- Patients who cannot tolerate surgery;
- the subjects cannot comply with the follow-up or affect the scientific and integrity of the study;
- Other patients who were not suitable for inclusion as assessed by clinicians.
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, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Haidian
Bingchuan Liu, +86 18310188678, liubc@bjmu.edu.cn
About this study
The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society.
- Conditions
- Bone Defects
- Being tested
- 3D printed prostheses
- Keywords
- 3D printing technology; bone defects; clinical effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed prosthesesDevice
3D printed prostheses
| Study group | Role | What they receive |
|---|---|---|
| Traumatic bone defect in lower limb | Traumatic bone defect in lower limb Receives: Device: 3D printed prostheses | |
| Infective lower limb bone defect | Infective lower limb bone defect Receives: Device: 3D printed prostheses | |
| Neoplastic bone defect in lower limb | Neoplastic bone defect in lower limb Receives: Device: 3D printed prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of implant stability, new bone growth- limb length
X-ray X、CT images
Measured: post-operative 1.3.6.12.24.36 months
Evaluation of bone healing
computed tomography (CT)
Measured: post-operative 3.6.12.24.36 months
Secondary outcomes (5)
Pain assessment
Visual Analog Score (VAS), total score is 10, "0" represents no pain, "10" represents the most unbearable pain
Measured: post-operative 1.3.6.12.24.36 months
Evaluation of life quality and health status.
36-item short form survery (SF-36) questionnaire, it includes 8 itmem, namely physical functioning, vitality, bodily pain, general health, social functioning, role physical, role emotional, mental health. The maximum score of each item is 100, higher score represents better result.
Measured: post-operative 1.3.6.12.24.36 months
Evaluation of knee function
hospital for special surgery (HSS) score. The maximum score of HSS is 100, higher score represents better result.
Measured: post-operative 1.3.6.12.24.36 months
Evaluation of hip function
Harris score, The maximum score of Harris score is 100, higher score represents better result.
Measured: post-operative 1.3.6.12.24.36 months
Evaluation of ankle function
American Orthopaedic Foot \& Ankle Society (AOFAS) score，The maximum score of AOFAS score is 100, higher score represents better result.
Measured: post-operative 1.3.6.12.24.36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion31 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 DefectsStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269354
- Sponsor's protocol ID
- 20231121-71479
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology
- ClinicalTrials.gov ID
- NCT06269354
- Acronym / sponsor ID
- 20231121-71479
- Conditions
- Bone Defects
- Keywords
- 3D printing technology; bone defects; clinical effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2024 (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 clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traumatic bone defect in lower limb | – | Device: 3D printed prosthesesTraumatic bone defect in lower limb |
| Infective lower limb bone defect | – | Device: 3D printed prosthesesInfective lower limb bone defect |
| Neoplastic bone defect in lower limb | – | Device: 3D printed prosthesesNeoplastic bone defect in lower limb |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower limb defects
Key inclusion criteria (6 listed)
- Patients with traumatic lower limb bone defect;
- Infected lower limb bone defect patients;
- Patients with neoplastic lower limb bone defect;
- The above reasons caused bone defects of more than 5CM
- at least 18 years of age;
Key exclusion criteria (4 listed)
- Patients who do not agree to the use of 3D printed microporous titanium alloy prostheses;
- Patients who cannot tolerate surgery;
- the subjects cannot comply with the follow-up or affect the scientific and integrity of the study;
- Other patients who were not suitable for inclusion as assessed by clinicians.
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 |
|---|---|---|
| 3D printed prostheses3D printed prostheses | Device | Infective lower limb bone defect, Neoplastic bone defect in lower limb, Traumatic bone defect in lower limb |
Primary outcome
Evaluation of implant stability, new bone growth- limb length
Time frame: post-operative 1.3.6.12.24.36 months
X-ray X、CT images
Evaluation of bone healing
Time frame: post-operative 3.6.12.24.36 months
computed tomography (CT)
5 secondary outcomes
Pain assessment
Time frame: post-operative 1.3.6.12.24.36 months
Evaluation of life quality and health status.
Time frame: post-operative 1.3.6.12.24.36 months
Evaluation of knee function
Time frame: post-operative 1.3.6.12.24.36 months
Evaluation of hip function
Time frame: post-operative 1.3.6.12.24.36 months
Evaluation of ankle function
Time frame: post-operative 1.3.6.12.24.36 months
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 21 Feb 2024.
- 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?
An observational study of Bone Defects, run by Peking University Third 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Feb 2024. 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 Bingchuan Liu, Doctor (+86 18310188678, liubc@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of implant stability, new bone growth- limb length (time frame: post-operative 1.3.6.12.24.36 months). The study lists 2 primary outcomes in all. 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 21 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.