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

Recruiting

• Conditions: Bone Metastases

• Registration Number: NCT06918860
• Lead Sponsor: Costantino Errani

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-05-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of implant survival	through study completion, an average of 1 year	Assess the longevity associated with the different surgical treatments used for proximal femur bone metastases.
Analysis of complications	At baseline ( T0)	Assess the post-operative complications associated with the different surgical treatments used for proximal femur bone metastases.
Analysis of functional score	1 year	Assess the functional score associated with the different surgical treatments used for proximal femur bone metastases.

Trial Locations

Locations (1)

Irccs Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Emilia-Romagna, Italy