NCT06486506

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

June 27, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Proximal Femur Reconstructionprimary bone tumorsimaging

Outcome Measures

Primary Outcomes (1)

  • longevity of the reconstruction

    evaluation of the longevity of the reconstruction, meaning reconstruction failure-free survival after surgery

    At baseline (Day 0)

Secondary Outcomes (1)

  • Musculoskeletal tumour society (MSTS) functional evaluation

    at baseline (day 0)

Study Arms (1)

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

Other: Analysis

Interventions

Analysis and review of imaging and clinical data

Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36402508BACKGROUND
  • Menendez 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.

    PMID: 16906093BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Costantino Errani, MD

CONTACT

Roberta Laranga, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

April 29, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations