Evaluation of Tumor Resection and Reconstruction With Prosthetic Implants

ConditionBone Tumor
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-70
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

Musculoskeletal Tumor Society (MSTS) Score

Postoperative functional outcome assessed using the Musculoskeletal Tumor Society (MSTS) scoring system.

Time frame
At final follow-up
3

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
4

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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