Complex Limb Bone DeformityMAP-BDNCT07779278
Multistage Additive Manufacturing for Complex Limb Bone Deformity Reconstruction
An observational study of Complex Limb Bone Deformity and Limb Length Discrepancy, run by Peking University Third Hospital at 1 site in China.
Trial summary
Complex deformities of the limb bones may involve abnormal angulation, limb or bone shortening, abnormal rotation and structural bone loss. These deformities can result from previous trauma, bone nonunion, infection, tumour resection, congenital or developmental conditions, previous surgery or failed reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Limb Bone Deformity, Limb Length Discrepancy, Angular Deformity
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Jul 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of consecutively identified adults receiving care at participating tertiary referral hospitals for complex deformity of a major upper- or lower-limb bone. Eligible deformities may result from post-traumatic malunion or nonunion, infection-related sequelae, tumour-related bone resection, congenital or developmental conditions, iatrogenic deformity or failed previous reconstruction. Participants may have angular deformity, shortening, rotational deformity or a combination of these, together with structural bone deficiency requiring patient-specific reconstruction. Eligibility for treatment and all surgical decisions will be determined by the treating multidisciplinary team independently of study participation.
Who may be able to join
- Age 18 years or older. Complex deformity involving a major upper- or lower-limb bone, including the humerus, radius, ulna, femur or tibia.
- Angular deformity, shortening, rotational deformity or any combination of these.
- Structural bone deficiency present before treatment or anticipated after corrective osteotomy, debridement or bone resection.
- The treating multidisciplinary team determines that a patient-specific additively manufactured implant is clinically indicated to restore skeletal continuity, length, alignment, rotation or mechanical load transfer.
- Ability to undergo CT-based three-dimensional planning and the planned multistage reconstructive treatment.
- Ability to provide written informed consent and willingness to complete 12 months of follow-up after definitive reconstruction.
Who cannot join
- Isolated osteoarthritis-related deformity without a reconstructive limb bone defect.
- Acute fracture without an established deformity or structural bone deficiency requiring patient-specific reconstruction.
- Uncontrolled systemic infection. Severe vascular insufficiency or a soft-tissue condition that precludes definitive reconstruction.
- Anticipated inability to achieve adequate debridement when required, viable soft-tissue coverage or stable fixation.
- Known allergy or contraindication to the implant material. Pregnancy when the required imaging or surgery would be inappropriate. Inability to comply with rehabilitation or outcome assessments. Participation in another clinical study that could materially affect the study outcomes.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Clinical Validation of a Multistage Additive Manufacturing Pathway for Complex Limb Bone Deformity Reconstruction
Complex deformities of the limb bones may involve abnormal angulation, limb or bone shortening, abnormal rotation and structural bone loss. These deformities can result from previous trauma, bone nonunion, infection, tumour resection, congenital or developmental conditions, previous surgery or failed reconstruction. Treatment is challenging because correction of the deformity and reconstruction of the remaining bone defect often require several coordinated surgical stages.
This multicentre prospective observational cohort study will evaluate the clinical outcomes of a multistage treatment pathway that incorporates three-dimensional imaging, computer-assisted surgical planning, additive manufacturing and patient-specific porous Ti6Al4V implants. Treatment decisions and the selection of surgical procedures will be made by the treating multidisciplinary team according to each patient's clinical condition and will not be assigned by the study.
The study will include 30 adults with complex deformity of a major upper- or lower-limb bone. Participants will be followed for 12 months after definitive reconstruction. The study will evaluate maintenance of deformity correction and implant stability, restoration of bone length, angular and rotational correction, radiographic bone-implant integration, limb function, pain, progression to functional loading, reoperations and adverse events.
Read the detailed description
Complex limb bone deformities may arise from post-traumatic malunion or nonunion, infection-related sequelae, tumour-related bone resection, congenital or developmental abnormalities, iatrogenic deformity or failure of previous reconstruction. Affected patients may have shortening, coronal or sagittal angulation, axial rotational deformity and structural bone deficiency, frequently accompanied by compromised soft tissue and multiple previous operations. Successful reconstruction therefore requires restoration of bone length, alignment and rotation, together with reconstruction of a stable skeletal column.
This is a multicentre, prospective observational cohort study involving 30 adult participants. The study will observe patients who receive a multistage additive manufacturing pathway as part of their clinical care. Eligibility for treatment and all clinical decisions, including the timing and type of surgery, will be determined by the treating multidisciplinary team independently of study participation. The study will not randomise participants, assign treatment or mandate a comparator procedure.
The clinical pathway may comprise three principal stages. The first stage consists of aetiology-specific preparation and definition of the reconstructive defect. Infection-related cases may require radical debridement, deep-tissue microbiological sampling, temporary stabilisation and antimicrobial treatment. Tumour-related cases may undergo oncologically appropriate resection. Patients with aseptic malunion, nonunion, developmental deformity or failed previous reconstruction may undergo corrective osteotomy, implant removal, nonunion-site preparation, soft-tissue release or other clinically indicated procedures.
The second stage consists of three-dimensional deformity analysis and restoration of bone length, alignment and rotation. Thin-slice computed tomography and calibrated radiographs will be used to construct a patient-specific anatomical model and quantify shortening, coronal and sagittal angulation, axial rotation and the anticipated bone defect after correction. Angular and rotational deformities may be corrected acutely when permitted by neurovascular and soft-tissue conditions. Patients with substantial shortening, multiplanar deformity or soft-tissue contracture may undergo gradual distraction and correction using circular or monolateral external fixation.
The third stage consists of definitive patient-specific reconstruction. After the planned correction has been achieved and the treating team confirms that the patient is ready for reconstruction, a porous Ti6Al4V implant will be designed for the corrected anatomy and manufactured using additive manufacturing. Patient-specific guides may be used to transfer the virtual plan to surgery. The implant will be stabilised using an intramedullary nail, locking plate, screws, integrated fixation structures or a combination selected according to the anatomical and mechanical requirements.
Postoperative rehabilitation will be individualised according to soft-tissue healing, bone quality, fixation stability and radiographic findings. Lower-limb participants will progress from protected or partial weight-bearing to full weight-bearing, whereas upper-limb participants will progress from protected motion to unrestricted functional loading.
Clinical and imaging assessments will be performed at baseline, during treatment and approximately 1, 3, 6 and 12 months after definitive reconstruction. The study will evaluate the clinical success and safety of the complete pathway, including correction accuracy, implant stability, radiographic bone-implant integration, limb-specific function, pain, health status, functional loading, reoperations and adverse events.
- Conditions
- Complex Limb Bone Deformity, Limb Length Discrepancy, Angular Deformity, Rotational Deformity, Long Bone Defect
- Keywords
- Additive Manufacturing, 3D Printing, Patient-Specific Implant, Porous Ti6Al4V, Long Bone Reconstruction, Limb Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multistage Additive Manufacturing Reconstruction Cohort | Adults with complex deformity of a major upper- or lower-limb bone who undergo a multistage additive manufacturing reconstruction pathway as part of routine clinical care. The deformity may include angulation, shortening, abnormal rotation and structural bone deficiency and may result from post-traumatic malunion or nonunion, infection-related sequelae, tumour-related resection, congenital or developmental conditions, iatrogenic deformity or failed previous reconstruction. The clinical pathway may include aetiology-specific preparation, CT-based three-dimensional planning, corrective osteotomy, acute or gradual deformity correction, patient-specific surgical guides, and definitive reconstruction using a patient-specific additively manufactured porous Ti6Al4V implant with individualised fixation. Treatment decisions are made independently by the treating multidisciplinary team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Reconstruction Success
Clinical reconstruction success is a composite outcome requiring all of the following criteria: (1) the patient-specific implant remains in situ without removal or component revision for mechanical failure; (2) no deep infection or other aetiology-specific event requires implant removal or unplanned major reconstruction; (3) radiographs show a stable implant and fixation construct without clinically important migration, subsidence, implant fracture, fixation failure or progressive loss of correction; and (4) the reconstructed limb permits functional use appropriate to the anatomical region. Participants meeting all four criteria will be classified as having clinical reconstruction success. The number and percentage of participants meeting the composite outcome will be reported.
Measured: 12 months after definitive reconstruction
Secondary outcomes (1)
Percentage of Participants Achieving the Planned Deformity Correction
Achievement of the planned deformity correction will be assessed by comparing postoperative CT or calibrated radiographic measurements with the patient-specific virtual plan. Correction will be classified as successful when all applicable criteria are met: residual length deviation of 10 mm or less, coronal and sagittal angular deviation of 5 degrees or less, and axial rotational deviation of 10 degrees or less. Only deformity components present and included in the preoperative plan will be evaluated for each participant. The number and percentage of participants meeting all applicable correction criteria will be reported.
Measured: Within 1 month after definitive reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Limb 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
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
- NCT07779278
- Sponsor's protocol ID
- AM-2608
- Acronym
- MAP-BD
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Multistage Additive Manufacturing Pathway for Complex Limb Bone Deformity Reconstruction
- ClinicalTrials.gov ID
- NCT07779278
- Acronym / sponsor ID
- MAP-BD / AM-2608
- Conditions
- Complex Limb Bone Deformity, Limb Length Discrepancy, Angular Deformity, Rotational Deformity, Long Bone Defect
- Keywords
- Additive Manufacturing, 3D Printing, Patient-Specific Implant, Porous Ti6Al4V, Long Bone Reconstruction, Limb Reconstruction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 21 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.
Complex deformities of the limb bones may involve abnormal angulation, limb or bone shortening, abnormal rotation and structural bone loss. These deformities can result from previous trauma, bone nonunion, infection, tumour resection, congenital or developmental conditions, previous surgery or failed reconstruction. Treatment is challenging because correction of the deformity and reconstruction of the remaining bone defect often require several coordinated surgical stages.
This multicentre prospective observational cohort study will evaluate the clinical outcomes of a multistage treatment pathway that incorporates three-dimensional imaging, computer-assisted surgical planning, additive manufacturing and patient-specific porous Ti6Al4V implants. Treatment decisions and the selection of surgical procedures will be made by the treating multidisciplinary team according to each patient's clinical condition and will not be assigned by the study.
The study will include 30 adults with complex deformity of a major upper- or lower-limb bone. Participants will be followed for 12 months after definitive reconstruction. The study will evaluate maintenance of deformity correction and implant stability, restoration of bone length, angular and rotational correction, radiographic bone-implant integration, limb function, pain, progression to functional loading, reoperations and adverse events.
Detailed description
Complex limb bone deformities may arise from post-traumatic malunion or nonunion, infection-related sequelae, tumour-related bone resection, congenital or developmental abnormalities, iatrogenic deformity or failure of previous reconstruction. Affected patients may have shortening, coronal or sagittal angulation, axial rotational deformity and structural bone deficiency, frequently accompanied by compromised soft tissue and multiple previous operations. Successful reconstruction therefore requires restoration of bone length, alignment and rotation, together with reconstruction of a stable skeletal column.
This is a multicentre, prospective observational cohort study involving 30 adult participants. The study will observe patients who receive a multistage additive manufacturing pathway as part of their clinical care. Eligibility for treatment and all clinical decisions, including the timing and type of surgery, will be determined by the treating multidisciplinary team independently of study participation. The study will not randomise participants, assign treatment or mandate a comparator procedure.
The clinical pathway may comprise three principal stages. The first stage consists of aetiology-specific preparation and definition of the reconstructive defect. Infection-related cases may require radical debridement, deep-tissue microbiological sampling, temporary stabilisation and antimicrobial treatment. Tumour-related cases may undergo oncologically appropriate resection. Patients with aseptic malunion, nonunion, developmental deformity or failed previous reconstruction may undergo corrective osteotomy, implant removal, nonunion-site preparation, soft-tissue release or other clinically indicated procedures.
The second stage consists of three-dimensional deformity analysis and restoration of bone length, alignment and rotation. Thin-slice computed tomography and calibrated radiographs will be used to construct a patient-specific anatomical model and quantify shortening, coronal and sagittal angulation, axial rotation and the anticipated bone defect after correction. Angular and rotational deformities may be corrected acutely when permitted by neurovascular and soft-tissue conditions. Patients with substantial shortening, multiplanar deformity or soft-tissue contracture may undergo gradual distraction and correction using circular or monolateral external fixation.
The third stage consists of definitive patient-specific reconstruction. After the planned correction has been achieved and the treating team confirms that the patient is ready for reconstruction, a porous Ti6Al4V implant will be designed for the corrected anatomy and manufactured using additive manufacturing. Patient-specific guides may be used to transfer the virtual plan to surgery. The implant will be stabilised using an intramedullary nail, locking plate, screws, integrated fixation structures or a combination selected according to the anatomical and mechanical requirements.
Postoperative rehabilitation will be individualised according to soft-tissue healing, bone quality, fixation stability and radiographic findings. Lower-limb participants will progress from protected or partial weight-bearing to full weight-bearing, whereas upper-limb participants will progress from protected motion to unrestricted functional loading.
Clinical and imaging assessments will be performed at baseline, during treatment and approximately 1, 3, 6 and 12 months after definitive reconstruction. The study will evaluate the clinical success and safety of the complete pathway, including correction accuracy, implant stability, radiographic bone-implant integration, limb-specific function, pain, health status, functional loading, reoperations and adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multistage Additive Manufacturing Reconstruction Cohort | – | –Adults with complex deformity of a major upper- or lower-limb bone who undergo a multistage additive manufacturing reconstruction pathway as part of routine clinical care. The deformity may include angulation, shortening, abnormal rotation and structural bone deficiency and may result from post-traumatic malunion or nonunion, infection-related sequelae, tumour-related resection, congenital or developmental conditions, iatrogenic deformity or failed previous reconstruction. The clinical pathway may include aetiology-specific preparation, CT-based three-dimensional planning, corrective osteotomy, acute or gradual deformity correction, patient-specific surgical guides, and definitive reconstruction using a patient-specific additively manufactured porous Ti6Al4V implant with individualised fixation. Treatment decisions are made independently by the treating multidisciplinary team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of consecutively identified adults receiving care at participating tertiary referral hospitals for complex deformity of a major upper- or lower-limb bone. Eligible deformities may result from post-traumatic malunion or nonunion, infection-related sequelae, tumour-related bone resection, congenital or developmental conditions, iatrogenic deformity or failed previous reconstruction. Participants may have angular deformity, shortening, rotational deformity or a combination of these, together with structural bone deficiency requiring patient-specific reconstruction. Eligibility for treatment and all surgical decisions will be determined by the treating multidisciplinary team independently of study participation.
Key inclusion criteria (6 listed)
- Age 18 years or older. Complex deformity involving a major upper- or lower-limb bone, including the humerus, radius, ulna, femur or tibia.
- Angular deformity, shortening, rotational deformity or any combination of these.
- Structural bone deficiency present before treatment or anticipated after corrective osteotomy, debridement or bone resection.
- The treating multidisciplinary team determines that a patient-specific additively manufactured implant is clinically indicated to restore skeletal continuity, length, alignment, rotation or mechanical load transfer.
- Ability to undergo CT-based three-dimensional planning and the planned multistage reconstructive treatment.
Key exclusion criteria (5 listed)
- Isolated osteoarthritis-related deformity without a reconstructive limb bone defect.
- Acute fracture without an established deformity or structural bone deficiency requiring patient-specific reconstruction.
- Uncontrolled systemic infection. Severe vascular insufficiency or a soft-tissue condition that precludes definitive reconstruction.
- Anticipated inability to achieve adequate debridement when required, viable soft-tissue coverage or stable fixation.
- Known allergy or contraindication to the implant material. Pregnancy when the required imaging or surgery would be inappropriate. Inability to comply with rehabilitation or outcome assessments. Participation in another clinical study that could materially affect the study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Clinical Reconstruction Success
Time frame: 12 months after definitive reconstruction
Clinical reconstruction success is a composite outcome requiring all of the following criteria: (1) the patient-specific implant remains in situ without removal or component revision for mechanical failure; (2) no deep infection or other aetiology-specific event requires implant removal or unplanned major reconstruction; (3) radiographs show a stable implant and fixation construct without clinically important migration, subsidence, implant fracture, fixation failure or progressive loss of correction; and (4) the reconstructed limb permits functional use appropriate to the anatomical region. Participants meeting all four criteria will be classified as having clinical reconstruction success. The number and percentage of participants meeting the composite outcome will be reported.
1 secondary outcome
Percentage of Participants Achieving the Planned Deformity Correction
Time frame: Within 1 month after definitive reconstruction
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 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Complex Limb Bone Deformity and Limb Length Discrepancy, 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 5 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: enrolling by invitation, as of the sponsor's last update on 21 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Reconstruction Success (time frame: 12 months after definitive reconstruction). 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 Aug 2026.