An observational study in Bone Tumor, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 100 is close to the median of 101 across 82 observational studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with primary or secondary bone tumors treated at the Policlinico A. Gemelli
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of primary malignant or locally aggressive benign bone tumors, or secondary bone lesions with a primary diagnosis of breast, lung, prostate, kidney, or thyroid cancer;
Extensive bone loss precluding the use of currently available prostheses or standard surgical techniques;
Use of modular or custom-made prostheses produced with 3D-printing technology; minimum follow-up of 12 months;
(For patients in the retrospective phase) completion of evaluation questionnaires during outpatient follow-ups;
Obtaining , except for deceased patients enrolled in the retrospective phase of the study.
Exclusion Criteria:
Patients with disease spread to other bone segments;
Age \<30 years or >70 years;
Patients who have undergone previous surgical procedures on the involved segment;
Follow-up of less than 1 year;
Incomplete clinical or radiological data sets;
Inability to obtain , except for deceased patients enrolled in the retrospective phase of the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky Performance Status
Postoperative quality of life and functional status assessed using the Karnofsky Performance Status score.
Time frame: From enrollment for at least one year
Musculoskeletal Tumor Society (MSTS) Score
Postoperative functional outcome assessed using the Musculoskeletal Tumor Society (MSTS) scoring system.
Time frame: At final follow-up
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
Time frame: From enrollment for at least one year
Oxford Knee Score
Knee functional outcome assessed using the Oxford Knee Score in patients with knee involvement
Time frame: From enrollment for at least one year
Harris Hip Score
Hip functional outcome assessed using the Harris Hip Score in patients with hip involvement.
Time frame: From enrollment for at least one year
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
Time frame: From enrollment for at least one year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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