Clinical Validation of a Multistage Additive Manufacturing Pathway for Complex Limb Bone Deformity Reconstruction

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.