Evaluation of Tumor Resection and Reconstruction With Prosthetic Implants

Official title

Valutazione Resezioni Oncologiche e Ricostruzione Con Utilizzo di Impianti Protesici in Chirurgia Oncologica Ortopedica (Evaluation of Oncologic Resections and Reconstruction Using Prosthetic Implants in Orthopedic Oncologic Surgery)

Overview

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.

Primary outcome measures

• Karnofsky Performance Status [Time frame: From enrollment for at least one year]
• Musculoskeletal Tumor Society (MSTS) Score [Time frame: At final follow-up]
• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score [Time frame: From enrollment for at least one year]
• Oxford Knee Score [Time frame: From enrollment for at least one year]
• Harris Hip Score [Time frame: From enrollment for at least one year]

Secondary outcome measures (1)

• Incidence of postoperative complications [Time frame: From enrollment for at least one year]

Eligibility criteria

Inclusion criteria

• Age between 30 and 70 years;

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 Informed Consent, 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 Informed Consent, except for deceased patients enrolled in the retrospective phase of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Sambri A, Zucchini R, Giannini C, Zamparini E, Viale P, Donati DM, De Paolis M. Silver-coated (PorAg(R)) endoprosthesis can be protective against reinfection in the treatment of tumor prostheses infection. Eur J Orthop Surg Traumatol. 2020 Dec;30(8):1345-1353. doi: 10.1007/s00590-020-02705-3. Epub 2020 May 24. PMID 32449080
• Donati F, Di Giacomo G, D'Adamio S, Ziranu A, Careri S, Rosa M, Maccauro G. Silver-Coated Hip Megaprosthesis in Oncological Limb Savage Surgery. Biomed Res Int. 2016;2016:9079041. doi: 10.1155/2016/9079041. Epub 2016 Aug 23. PMID 27642605
• Wang X, Liu Y, Zhang M, Zhai D, Wang Y, Zhuang H, Ma B, Qu Y, Yu X, Ma J, Ma H, Yao Q, Wu C. 3D Printing of Black Bioceramic Scaffolds with Micro/Nanostructure for Bone Tumor-Induced Tissue Therapy. Adv Healthc Mater. 2021 Nov;10(21):e2101181. doi: 10.1002/adhm.202101181. Epub 2021 Sep 15. PMID 34523255
• Zhu C, He M, Sun D, Huang Y, Huang L, Du M, Wang J, Wang J, Li Z, Hu B, Song Y, Li Y, Feng G, Liu L, Zhang L. 3D-Printed Multifunctional Polyetheretherketone Bone Scaffold for Multimodal Treatment of Osteosarcoma and Osteomyelitis. ACS Appl Mater Interfaces. 2021 Oct 13;13(40):47327-47340. doi: 10.1021/acsami.1c10898. Epub 2021 Sep 29. PMID 34587454
• Girolami M, Boriani S, Bandiera S, Barbanti-Brodano G, Ghermandi R, Terzi S, Tedesco G, Evangelisti G, Pipola V, Gasbarrini A. Biomimetic 3D-printed custom-made prosthesis for anterior column reconstruction in the thoracolumbar spine: a tailored option following en bloc resection for spinal tumors : Preliminary results on a case-series of 13 patients. Eur Spine J. 2018 Dec;27(12):3073-3083. doi: 1 PMID 30039254
• Liang H, Yang Y, Guo W, Yan L, Tang X, Li D, Qu H, Zang J, Du Z. Elbow hemiarthroplasty with a 3D-printed megaprosthesis for defects of the distal humerus or proximal ulna after tumour resection : a preliminary report. Bone Joint J. 2022 Jun;104-B(6):747-757. doi: 10.1302/0301-620X.104B6.BJJ-2021-1516.R1. PMID 35638204
• Park JH, Jung HW, Jang WY. The usefulness of a three-dimensional printed segmental scapula prosthesis for recovering shoulder function in a patient with scapula chondrosarcoma: A case report. Medicine (Baltimore). 2021 Feb 26;100(8):e24817. doi: 10.1097/MD.0000000000024817. PMID 33663101
• Beltrami G, Ristori G, Nucci AM, Galeotti A, Tamburini A, Scoccianti G, Campanacci D, Innocenti M, Capanna R. Custom-Made 3D-Printed Implants as Novel Approach to Reconstructive Surgery after Oncologic Resection in Pediatric Patients. J Clin Med. 2021 Mar 4;10(5):1056. doi: 10.3390/jcm10051056. PMID 33806387

Identifiers

NCT: NCT07337018 · 7224

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗