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Trial Title:
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.
NCT ID:
NCT05969470
Condition:
Bone Metastases
Pathological Fracture
Pathological Fracture, Left Femur
Pathological Fracture, Right Femur
Conditions: Official terms:
Neoplasm Metastasis
Fractures, Bone
Fractures, Spontaneous
Conditions: Keywords:
Long Intramedullary Nails
Short Intramedullary Nails
Bone Metastases
Pathological Fracture of Femur
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Internal fixation with short intramedullary nails
Description:
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.
Arm group label:
Short intramedullary nails
Intervention type:
Device
Intervention name:
Internal fixation with long intramedullary nails
Description:
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.
Arm group label:
Long intramedullary nails
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 31, 2023
Completion date:
June 2027
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital, Yun-Lin Branch
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital Hsin-Chu Branch
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05969470
