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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jul 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two types of surgical nails used to fix fractures in the thigh bone (femur) caused by cancer spread (bone metastases). Specifically, it compares short intramedullary nails with long ones to see which type leads to better outcomes for patients with fractures or those who are at risk of fractures due to cancer. The trial will look at factors like how often new cancer spreads to other parts of the body, the need for additional surgeries, complications, and overall quality of life after the treatment.

To participate, patients must have a specific type of thigh bone fracture that can be treated with these nails and be willing to follow the trial's guidelines. Key eligibility criteria include being diagnosed with a femur fracture caused by cancer and not having other more suitable treatment options. If eligible, participants will be randomly assigned to receive either a short or long nail for their surgery. It’s important for potential participants to communicate effectively and understand the trial process, as well as be willing to cooperate with follow-up appointments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Femur (impending) pathological fracture that is suitable for intramedullary nail fixation as determined by the physician
• • Patient is willing to participate in this clinical trial and cooperate with follow-up
• Exclusion Criteria:
• • The patient has a more appropriate treatment alternative to single intramedullary nail fixation as determined by the multidisciplinary decision, such as,
• • The metastatic lesions involved the femur head
• • The metastatic lesions involved the pelvis
• • The metastatic lesions compromised the greater or lesser trochanter to a certain extent that arthroplasty was indicated
• • The metastatic lesions involved/occurred more distal than the intertrochanteric line
• • There are justified, clinically significant rationales that either long or short intramedullary nails be a more appropriate treatment during pre-operative assessment
• • The patient has imaging-confirmed distant femoral metastases before treatment
• • Patient has renal cell carcinoma or sarcoma
• • Patient is unable to cooperate with follow-up or to understand the trial protocol
• • Patient is unable to communicate in Chinese