Status:
NOT_YET_RECRUITING
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital Hsin-Chu Branch
Conditions:
Bone Metastases
Pathological Fracture
Eligibility:
All Genders
20+ years
Phase:
NA
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 impen...
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 gre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05969470
Start Date
August 31 2023
End Date
June 1 2027
Last Update
August 18 2023
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