Bone TumorRERIONCT07337018

Evaluation of Tumor Resection and Reconstruction With Prosthetic Implants

An observational study of Bone Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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. Read more about this study

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Bone Tumor
How many people: 100 participants
Where: No sites listed yet
Study dates: 1 Jan 2026to 30 Nov 2028
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with primary or secondary bone tumors treated at the Policlinico A. Gemelli

Who may be able to join

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.

Who cannot join

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

About this study

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)

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.

Conditions: Bone Tumor
Medical subject headings: Bone Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Karnofsky Performance Status
Postoperative quality of life and functional status assessed using the Karnofsky Performance Status score.
Measured: From enrollment for at least one year
Musculoskeletal Tumor Society (MSTS) Score
Postoperative functional outcome assessed using the Musculoskeletal Tumor Society (MSTS) scoring system.
Measured: 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
Measured: From enrollment for at least one year
Oxford Knee Score
Knee functional outcome assessed using the Oxford Knee Score in patients with knee involvement
Measured: From enrollment for at least one year
Harris Hip Score
Hip functional outcome assessed using the Harris Hip Score in patients with hip involvement.
Measured: 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
Measured: From enrollment for at least one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202630 Nov 2028

First posted13 Jan 2026
Study start1 Jan 2026 (estimated)
Primary completion30 Nov 2027 (estimated)
Study completion30 Nov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Bone TumorStudies of the same condition, open and under way.
More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07337018
Sponsor's protocol ID: 7224
Acronym: RERIO
Status last verified: Dec 2025
First submitted: 11 Dec 2025
Last updated: 13 Jan 2026
Results posted: No
FDA-regulated drug: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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: 10.1007/s00586-018-5708-8. Epub 2018 Jul 23.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 33806387
Gursan O, Celtik M, Yanik B, Husemoglu RB, Havitcioglu H. Three-Dimensionally-Printed Joint-Preserving Prosthetic Reconstruction of Massive Bone Defects After Malignant Tumor Resection of the Proximal Tibia. Cureus. 2021 Mar 9;13(3):e13784. doi: 10.7759/cureus.13784.
PubMed 33842159
Yang QD, Mu MD, Tao X, Tang KL. Three-dimensional printed talar prosthesis with biological function for giant cell tumor of the talus: A case report and review of the literature. World J Clin Cases. 2021 May 6;9(13):3147-3156. doi: 10.12998/wjcc.v9.i13.3147.
PubMed 33969102
Xu L, Qin H, Cheng Z, Jiang WB, Tan J, Luo X, Huang W. 3D-printed personalised prostheses for bone defect repair and reconstruction following resection of metacarpal giant cell tumours. Ann Transl Med. 2021 Sep;9(18):1421. doi: 10.21037/atm-21-3400.
PubMed 34733973
Chen G, Yin Y, Chen C. Limb-salvage surgery using personalized 3D-printed porous tantalum prosthesis for distal radial osteosarcoma: A case report. Medicine (Baltimore). 2021 Nov 19;100(46):e27899. doi: 10.1097/MD.0000000000027899.
PubMed 34797342
Pu F, Liu J, Shi D, Huang X, Zhang J, Wang B, Wu Q, Zhang Z, Shao Z. Reconstruction With 3D-Printed Prostheses After Sacroiliac Joint Tumor Resection: A Retrospective Case-Control Study. Front Oncol. 2022 Jan 4;11:764938. doi: 10.3389/fonc.2021.764938. eCollection 2021.
PubMed 35059310
Wang S, Luo Y, Zhang Y, Wang Y, Zheng C, Tu C, Zhou Y. Case Report: Reconstruction of Medialis Malleolus (1/4 of the Ankle Joint) After Resection of Distal Tibia Tumor With an Uncemented Three-Dimensional-Printed Prosthesis. Front Surg. 2022 Mar 24;9:844334. doi: 10.3389/fsurg.2022.844334. eCollection 2022.
PubMed 35402484
Park JW, Kang HG. Application of 3-dimensional printing implants for bone tumors. Clin Exp Pediatr. 2022 Oct;65(10):476-482. doi: 10.3345/cep.2021.01326. Epub 2021 Dec 23.
PubMed 34942688

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bone Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07337018
Acronym / sponsor ID: RERIO / 7224
Conditions: Bone Tumor
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 30 Nov 2027 (estimated)
Study completion: 30 Nov 2028 (estimated)
First posted: 13 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with primary or secondary bone tumors treated at the Policlinico A. Gemelli

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Karnofsky Performance Status
Time frame: From enrollment for at least one year
Postoperative quality of life and functional status assessed using the Karnofsky Performance Status score.
Musculoskeletal Tumor Society (MSTS) Score
Time frame: At final follow-up
Postoperative functional outcome assessed using the Musculoskeletal Tumor Society (MSTS) scoring system.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time frame: From enrollment for at least one year
Upper-limb functional outcome assessed using the QuickDASH questionnaire in patients with upper extremity involvement
Oxford Knee Score
Time frame: From enrollment for at least one year
Knee functional outcome assessed using the Oxford Knee Score in patients with knee involvement
Harris Hip Score
Time frame: From enrollment for at least one year
Hip functional outcome assessed using the Harris Hip Score in patients with hip involvement.

1 secondary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Background: PubMed 32449080Sambri 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.
Background: PubMed 27642605Donati 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.
Background: PubMed 34523255Wang 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.
Background: PubMed 34587454Zhu 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.
Background: PubMed 30039254Girolami 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: 10.1007/s00586-018-5708-8. Epub 2018 Jul 23.
Background: PubMed 35638204Liang 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.
Background: PubMed 33663101Park 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.
Background: PubMed 33806387Beltrami 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.
Background: PubMed 33842159Gursan O, Celtik M, Yanik B, Husemoglu RB, Havitcioglu H. Three-Dimensionally-Printed Joint-Preserving Prosthetic Reconstruction of Massive Bone Defects After Malignant Tumor Resection of the Proximal Tibia. Cureus. 2021 Mar 9;13(3):e13784. doi: 10.7759/cureus.13784.
Background: PubMed 33969102Yang QD, Mu MD, Tao X, Tang KL. Three-dimensional printed talar prosthesis with biological function for giant cell tumor of the talus: A case report and review of the literature. World J Clin Cases. 2021 May 6;9(13):3147-3156. doi: 10.12998/wjcc.v9.i13.3147.
Background: PubMed 34733973Xu L, Qin H, Cheng Z, Jiang WB, Tan J, Luo X, Huang W. 3D-printed personalised prostheses for bone defect repair and reconstruction following resection of metacarpal giant cell tumours. Ann Transl Med. 2021 Sep;9(18):1421. doi: 10.21037/atm-21-3400.
Background: PubMed 34797342Chen G, Yin Y, Chen C. Limb-salvage surgery using personalized 3D-printed porous tantalum prosthesis for distal radial osteosarcoma: A case report. Medicine (Baltimore). 2021 Nov 19;100(46):e27899. doi: 10.1097/MD.0000000000027899.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Karnofsky Performance Status (time frame: From enrollment for at least one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07337018, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.