About this trial
Bone can be the site of primary malignant tumors or, more commonly, secondary lesions. The most frequent primary tumors are osteosarcoma, chondrosarcoma, and Ewing sarcoma, whereas the malignancies that most commonly metastasize to bone include breast, prostate, lung, kidney, and thyroid cancers.
For the treatment of these conditions-and, in some cases, for locally aggressive benign diseases-a surgical approach is often required, which may result in substantial bone loss. Most commercially available prostheses commonly used in orthopedic surgery are not always suitable, either because of the anatomical location of the procedure or the type of resection planned, and thus the extent of the bone defect to be reconstructed. Therefore, specific prosthetic implants designed for oncologic surgery are required.
For this reason, modular prostheses have been developed, allowing reconstruction of bone defects of varying sizes across different anatomical districts. In recent years, the development and use of 3D-printing technology for producing custom-made prostheses has also increased, with the aim of reconstructing bone defects in areas that are difficult to treat and achieving an accurate reproduction of the patient's anatomy. This technology enables reconstruction in a wide range of skeletal sites. Additionally, it allows for preoperative planning on printed anatomical models and opens the possibility of integrating materials with adjuvant-related properties into the prosthetic design, such as photothermal therapy or antimicrobial features.
Although numerous studies on this topic are available in the literature, they frequently involve small patient cohorts. There is therefore a need to expand case series with longer follow-ups to better assess the reliability and effectiveness of these treatment strategies in the development of reconstructive orthopedic oncologic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 30 and 70 years;
Disqualifiers
None
Trial population
Patients with primary or secondary bone tumors treated at the Policlinico A. Gemelli
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Karnofsky Performance Status
Postoperative quality of life and functional status assessed using the Karnofsky Performance Status score.
Musculoskeletal Tumor Society (MSTS) Score
Postoperative functional outcome assessed using the Musculoskeletal Tumor Society (MSTS) scoring system.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Upper-limb functional outcome assessed using the QuickDASH questionnaire in patients with upper extremity involvement
Oxford Knee Score
Knee functional outcome assessed using the Oxford Knee Score in patients with knee involvement
Secondary outcomes
Incidence of postoperative complications
Postoperative complications will be assessed through clinical evaluation and review of medical records, supported by imaging and laboratory findings when indicated. Complications include periprosthetic infection, implant loosening, wound dehiscence, dislocation (for implants including an articular component), and periprosthetic fracture. Each complication will be recorded as present or absent according to standard clinical diagnostic criteria
Locations
Sponsors and contacts
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