Analysis of Intramedullary Nail and Prosthetic Reconstruction After Surgical Treatment of Bone Metastases of Proximal Femur

NCT ID: NCT06918860

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2025-12-31

Brief Summary

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The investigators will collect data of patients treated surgically for impending or pathological fracture of the proximal femur due to bone metastases between 01/01/2000 and 31/12/2023 with IMN or THA or HHA or MegaTHA or Mega.

After pre-screening the databases of the respective sites, the investigators expect to find approximately a total of 600 patients. A review will be made from the medical records, radiological imaging, and histological data of partecipants.

Detailed Description

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Conditions

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Bone Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.

Analysis

Intervention Type OTHER

Analysis and review of imaging and clinical data

Interventions

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Analysis

Analysis and review of imaging and clinical data

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female adult patients surgically treated between 01/01/2000 and 31/12/2023 in Rizzoli Orthopaedic Institute and in Massachusetts General Hospital.
* Age ≥18 y (at the time of surgery)
* Patients with impending or pathological fracture due to bone metastases of the proximal femur (head/neck, intertrochanteric, subtrochanteric area).
* Patients who underwent either IMN or THA or HHA or Mega or MegaTHA.
* Patients with available clinical and imaging data.

Exclusion Criteria

* Patients with pathological or impending fracture of proximal femur due to primary bone tumor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Costantino Errani

OTHER

Sponsor Role lead

Responsible Party

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Costantino Errani

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Costantino Errani, MD

Role: CONTACT

0516366 ext. Ext. 103

Roberta Laranga, PhD

Role: CONTACT

0516366 ext. Ext. 5123

Facility Contacts

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Costantino Errani, MD

Role: primary

0516366 ext. Ext. 103

Roberta Laranga, PhD

Role: backup

0616366 ext. 5123

References

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Wedin R, Bauer HC. Surgical treatment of skeletal metastatic lesions of the proximal femur: endoprosthesis or reconstruction nail? J Bone Joint Surg Br. 2005 Dec;87(12):1653-7. doi: 10.1302/0301-620X.87B12.16629.

Reference Type BACKGROUND
PMID: 16326880 (View on PubMed)

Errani C, Mavrogenis AF, Cevolani L, Spinelli S, Piccioli A, Maccauro G, Baldini N, Donati D. Treatment for long bone metastases based on a systematic literature review. Eur J Orthop Surg Traumatol. 2017 Feb;27(2):205-211. doi: 10.1007/s00590-016-1857-9. Epub 2016 Sep 20.

Reference Type BACKGROUND
PMID: 27650452 (View on PubMed)

Araki N, Chuman H, Matsunobu T, Tanaka K, Katagiri H, Kunisada T, Hiruma T, Hiraga H, Morioka H, Hatano H, Asanuma K, Nishida Y, Hiraoka K, Okamoto T, Abe S, Watanuki M, Morii T, Sugiura H, Yoshida Y, Ohno T, Outani H, Yokoyama K, Shimose S, Fukuda H, Iwamoto Y. Factors associated with the decision of operative procedure for proximal femoral bone metastasis: Questionnaire survey to institutions participating the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group. J Orthop Sci. 2017 Sep;22(5):938-945. doi: 10.1016/j.jos.2017.05.012. Epub 2017 Jun 17.

Reference Type BACKGROUND
PMID: 28629828 (View on PubMed)

Other Identifiers

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BoneMetaProFe

Identifier Type: -

Identifier Source: org_study_id

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