Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.

Summary

The goal of this interventional randomized controlled trial is to compare the clinical outcomes in treating extremities pathological fractures (fractures of limbs caused by metastatic tumors) or impending pathological fractures with short or long intramedullary nails. The main questions it aims to answer are:

1. What is the rate of developing new distant metastasis of the operated extremities?
2. Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails?
3. Are there any differences when comparing the surgical-related complication, functional outcomes and life quality assessment between treating extremities (impending) pathological fractures with long or short intramedullary nails.

Participants who meet surgical indication will be randomized into either the long or short intramedullary nail group after informed consent. The patient will receive bone fixation with the corresponding prosthesis.

Conditions

• Bone Metastases
• Pathological Fracture
• Pathological Fracture, Left Femur
• Pathological Fracture, Right Femur

Interventions

DEVICE

Internal fixation with short intramedullary nails

Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a shorter intramedullary nail (defined as defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.

DEVICE

Internal fixation with long intramedullary nails

Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.

Sponsors & Collaborators

• National Taiwan University Hospital, Yun-Lin Branch

  collaborator OTHER

• National Taiwan University Hospital Hsin-Chu Branch

  collaborator OTHER

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Hsiang Chieh Hsieh, MD · Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-31

Primary Completion

2024-06-30

Completion

2027-06-30

FDA Device

Yes