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NCT Number: NCT03416959

Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones

The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),

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Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction

Exclusion criteria

  • Patients with bone metastases of the spine

Treatment and study plan

intramedullary fixation or endoprosthetic reconstruction

Procedure

Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction

Primary outcomes

  1. Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction

    Time frame: 24 months

    The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction

Secondary outcomes

  1. Survival in patients undergoing surgery for metastatic bone disease

    Time frame: 24 months

    Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific and laboratory tests

Other outcomes

  1. Prognostic factor regarding erythrocyte sedimentation rate

    Time frame: 24 months

    erythrocyte sedimentation rate (mm/h)

  2. Prognostic factor regarding C reactive protein

    Time frame: 24 months

    C reactive protein (mg/dl)

  3. Prognostic factor regarding Alkaline phosphatase

    Time frame: 24 months

    Alkaline phosphatase (U/L)

  4. Prognostic factor regarding white blood cells

    Time frame: 24 months

    white blood cells (10/mm)

  5. Prognostic factor regarding hemoglobin

    Time frame: 24 months

    hemoglobin (g/dl)

  6. Prognostic factor regarding Karnofsky score

    Time frame: 24 months

    Karnofsky score (0/100)

Study contacts

Contact information is provided by the study sponsor or research team.

Costantino Errani, MD

CONTACT

[email protected]

+390516366103

Davide M Donati, MD

CONTACT

[email protected]

+390516366012

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Prospective Bone Metastases Database

Acronym: BMD

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2018
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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