Bone TumorProFemuReNCT06486506
Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results
An observational study of Bone Tumor and Bone Cancer, run by Costantino Errani at 1 site in Italy.
Trial summary
From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023. A review will be made from the medical records, radiological imaging, and histological data of these patients Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone Tumor, Bone Cancer
- What is being tested?
- Analysis
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2024to 31 Dec 2026
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
Who may be able to join
- Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
- Age: 18-90 years old (at the time of primary surgery)
- Diagnosis of bone sarcoma
- Patients with available clinical and imaging data
Who cannot join
- At least one inclusion criterion not met
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Itituto Ortopedico Rizzoli
Bologna, BO, 40136
Costantino Errani, MD
About this study
From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023.
A review will be made from the medical records, radiological imaging, and histological data of these patients
- Conditions
- Bone Tumor, Bone Cancer
- Being tested
- Analysis
- Keywords
- Proximal Femur Reconstruction, primary bone tumors, imaging
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalysisOther
Analysis and review of imaging and clinical data
| Study group | Role | What they receive |
|---|---|---|
| Patients | Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023 Receives: Other: Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
longevity of the reconstruction
evaluation of the longevity of the reconstruction, meaning reconstruction failure-free survival after surgery
Measured: At baseline (Day 0)
Secondary outcomes (1)
Musculoskeletal tumour society (MSTS) functional evaluation
The MSTS questionnaire consists of six domains, each scored on a scale from 0 to 5, with a higher score indicating better function.
Measured: at baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start29 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Costantino Errani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Costantino Errani, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486506
- Sponsor's protocol ID
- ProFemuRe
- Acronym
- ProFemuRe
- Status last verified
- May 2026
- First submitted
- 27 Jun 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tobey D, Wing C, Calkins T, Heck RK. The Use of Proximal Femur Replacement for the Management of Oncologic Lesions in the Proximal Femur: A Review. Orthop Clin North Am. 2023 Jan;54(1):23-35. doi: 10.1016/j.ocl.2022.08.006. Epub 2022 Oct 23.
PubMed 36402508Menendez LR, Ahlmann ER, Kermani C, Gotha H. Endoprosthetic reconstruction for neoplasms of the proximal femur. Clin Orthop Relat Res. 2006 Sep;450:46-51. doi: 10.1097/01.blo.0000229332.91158.05.
PubMed 16906093
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results
- ClinicalTrials.gov ID
- NCT06486506
- Acronym / sponsor ID
- ProFemuRe / ProFemuRe
- Conditions
- Bone Tumor, Bone Cancer
- Keywords
- Proximal Femur Reconstruction, primary bone tumors, imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Costantino ErraniUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023.
A review will be made from the medical records, radiological imaging, and histological data of these patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: AnalysisMale and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
Key inclusion criteria (4 listed)
- Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
- Age: 18-90 years old (at the time of primary surgery)
- Diagnosis of bone sarcoma
- Patients with available clinical and imaging data
Key exclusion criteria (1 listed)
- At least one inclusion criterion not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnalysisAnalysis and review of imaging and clinical data | Other | Patients |
Primary outcome
longevity of the reconstruction
Time frame: At baseline (Day 0)
evaluation of the longevity of the reconstruction, meaning reconstruction failure-free survival after surgery
1 secondary outcome
Musculoskeletal tumour society (MSTS) functional evaluation
Time frame: at baseline (day 0)
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 26 May 2026.
- Background: PubMed 36402508Tobey D, Wing C, Calkins T, Heck RK. The Use of Proximal Femur Replacement for the Management of Oncologic Lesions in the Proximal Femur: A Review. Orthop Clin North Am. 2023 Jan;54(1):23-35. doi: 10.1016/j.ocl.2022.08.006. Epub 2022 Oct 23.
- Background: PubMed 16906093Menendez LR, Ahlmann ER, Kermani C, Gotha H. Endoprosthetic reconstruction for neoplasms of the proximal femur. Clin Orthop Relat Res. 2006 Sep;450:46-51. doi: 10.1097/01.blo.0000229332.91158.05.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Tumor and Bone Cancer, run by Costantino Errani at 1 site in Italy.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Costantino Errani, MD (0516366 ext. 103, costantino.errani@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
longevity of the reconstruction (time frame: At baseline (Day 0)). 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 NCT06486506, which also lists 2 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 26 May 2026.