Spots Global Cancer Trial Database for Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.

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Trial Identification

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

Official Title: Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial

Study ID: NCT05969470

Conditions

Bone Metastases

Pathological Fracture

Pathological Fracture, Left Femur

Pathological Fracture, Right Femur

Interventions

Internal fixation with short intramedullary nails

Internal fixation with long intramedullary nails

Study Description

Brief 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.

Detailed Description: Participants will be randomized into either long or short intramedullary nail groups. Participants in the long intramedullary nail 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, while patients in the short intramedullary nail group will be fixed with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6, and 12 months after surgery to analyze the patient's function, blood sampling values, and imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.