Can 3D-Printed implants rebuild severely deformed limbs?
NCT ID NCT07779278
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This study looks at whether custom-made, 3D-printed implants can help people with severe limb bone deformities—such as bending, shortening, or rotation—caused by injury, infection, or birth conditions. Researchers will follow 30 adults who receive these personalized implants as part of a multi-step surgical plan. The goal is to see if the implants stay stable, correct the deformity, and allow the limb to function normally over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Patient-specific porous titanium (Ti6Al4V) implants created via 3D printing, guided by computer-assisted surgical planning
- What this could lead to
- If successful, this approach could offer a more precise, personalized way to reconstruct severely deformed limb bones, potentially improving function and reducing the need for multiple surgeries.
- What could go wrong
- This is an early-stage observational study with only 30 participants, so results may not apply broadly. Risks include implant failure, infection, or incomplete bone healing.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
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