Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Fractures, Bone

Neoplasm Metastasis

Femoral Fractures

Fractures, Spontaneous

Neoplastic Processes

The patients receives bone fixation with short intramedullary nails for extremity metastases.

The patients receives bone fixation with long intramedullary nails for extremity metastases.

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.

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 longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.

Internal fixation with long intramedullary nails

Hsiang Chieh Hsieh, MD

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.

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.

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

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

Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%.

The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates physical, mental, and social health in adults and children. It's used to measure symptoms and other aspects of health status in a wide variety of chronic diseases. PROMIS-29 is a particular version of this system that covers multiple domains of health and function. It consists of 29 items in total, spanning seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain has four questions, with the exception of the pain interference domain, which has five. Each question is scored from 1-5, the higher score indicates better function or quality of life. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There's also a single question evaluating pain intensity, as assessed by pain intensity numeric rating scale.

Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death.

Percentage of demise at 1,3,6,12 months after the intervention

Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention

Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.	NCT05969470	Bone Metastases Pathological Fr... Pathological Fr... Pathological Fr...	Internal fixati... Internal fixati...	20 Years -	National Taiwan University Hospital
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.	NCT05969470	Bone Metastases Pathological Fr... Pathological Fr... Pathological Fr...	Internal fixati... Internal fixati...	20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for long intramedullary nails